Risk factors associated with in-hospital mortality patients with COVID-19 in Saudi Arabia.

Risk factors for in-hospital mortality of COVID-19 patients in Saudi Arabia have not been well studied. Previous reports from other countries have highlighted the effect of age, gender, clinical presentation and health conditions on the outcome of COVID-19 patients. Saudi Arabia has a different epidemiological structure with a predominance of young population, which calls for separate study. The objective of this study is to assess the predictors of mortality among hospitalized patients with COVID-19 in Saudi Arabia. This is a retrospective observational cohort study of hospitalized adult COVID-19 patients at two tertiary hospitals in Saudi Arabia between May to July 2020. Electronic charts were retrospectively reviewed comparing survivors and non-survivors in terms of demographic and clinical variables and comorbid conditions. A total of 564 hospitalized patients with COVID-19 were included in the study. The overall in-hospital mortality rate was 20%. The non-survivors were significantly older than survivors (59.4 ± 13.7 years and 50.5 ± 13.9 years respectively P< 0.001). Diabetes mellitus, hypertension, heart failure and ischemic heart disease were more prevalent among non-survivors (P< 0.001). The mean values of glycosylated hemoglobin HgA1C, D-dimer, ferritin, lactate dehydrogenase LDH, Alanin aminotransferase ALT and creatinine were significantly higher among non-survivors (P < 0.05). Multivariate logistic regression analysis revealed that age (aOR = 1.04; 95% CI 1.02-1.08; P < 0.01), chronic kidney disease (aOR = 4.04; 95% CI 1.11-14.77; P < 0.05), acute respiratory distress syndrome ARDS (aOR = 14.53; 95% CI 5.42-38.69; P < 0.01), Mechanical Ventilation (aOR = 10.57; 95% CI 5.74-23.59; P < 0.01), Shock (aOR = 3.85; 95% CI 1.02-14.57; P < 0.05), admission to intensive care unit (ICU) (aOR = 0.12; 95% CI 0.04-0.33; P < 0.01) and length of stay (aOR = 0.96; 95% CI 0.93-0.99; P < 0.05) were significant contributors towards mortality. The in-hospital mortality rate of COVID-19 patients admitted to tertiary hospitals in Saudi Arabia is high. Older age, chronic kidney disease and ARDS were the most important predictors of mortality.

Medication Error During the Day and Night Shift on Weekdays and Weekends: A Single Teaching Hospital Experience in Riyadh, Saudi Arabia.

BACKGROUND: The association between medication error incidence and time (day shift vs night shift) have not been extensively studied in Saudi Arabia, this study aimed to answer this question: is there a relationship between medication error incidence and time of the day (day shifts vs night shifts) on weekdays and weekends?. OBJECTIVE: To identify whether medication errors and their sub-categories are significantly different between day shifts, night shifts, during weekdays and weekends. METHODS: A retrospective analysis of medication errors reported by health-care practitioners from January 2018 to December 2019 through the Electronic-Occurrence Variance Reporting System (E-OVR) of a university teaching hospital in Riyadh, Saudi Arabia. Statistical analysis was used to determine the differences between the medication errors and their sub-categories and day and night shifts during weekdays (from Sunday to Thursday) and weekends (Friday and Saturday). RESULTS: A total of 2626 medication errors were reported over 2 years from January 2018 to December 2019. The most prevalent sub-category of medication errors was prescribing errors (55%), while the least common sub-category of medication errors was administration errors (0.6%). There was a statistically significant difference between medication errors and day of the week. Medication errors that happened on weekdays were greater than at weekends (P = 0.01). During weekends, medication errors were more likely to occur at the night shift compared to the day shift (P < 0.05). CONCLUSION: Timing of medication errors incidence is an important factor to be considered for improving the medication use process and improving patient safety. Further researches are needed that focus on intervention to reduce these errors, especially during night shifts.

Cardiovascular Risk Factors Among Patients Infected with COVID-19 in Saudi Arabia.

BACKGROUND: Coronavirus disease (COVID-19) is a global pandemic with more than 60 million cases worldwide and over 1.5 million deaths by March 2021. Its outbreak has caused a huge burden on healthcare systems all over the world. Several studies in the medical literature have suggested that patients with underlying cardiovascular disease (CVD) are at higher risk for developing severe symptoms, poor prognosis, and high mortality rates. The aim of this study was to assess the prevalence of CVD risk factors among COVID-19 patients based on the Framingham risk score (FRS), and to evaluate the association of CVD risk factors with clinical outcomes. PATIENTS AND METHODS: In this retrospective cross-sectional study, we identified 264 confirmed cases with COVID-19 at King Saud University Medical City in Riyadh, Saudi Arabia. Patients aged 18-80 years were included, and their electronic records were reviewed. They were classified into low, intermediate, and high risk of CVD according to FRS classification. RESULTS: Two-hundred-six patients (67% male) were included in this study. The mean age was 55.3 ± 15.1 years. Most patients had comorbidities: the most common were hypertension (48.1%), diabetes (45.1%), and ischemic heart disease (11.2%). More than half required intensive care admission, and 58 (28.2%) patients died. Pneumonia was the most frequently observed complication (85%), followed by mechanical ventilation (28.3%) and acute kidney injury (27.7%). Age, male gender, hypertension, and diabetes mellitus showed significant differences between FRS categories, and were associated with intermediate and high-risk groups of FRS (p < 0.05). Pneumonia and length of stay were associated with the Intermediate risk group of FRS. CONCLUSION: Cardiovascular disease risk factors are prevalent in Saudi patients infected with COVID-19. FRS could be a useful tool to identify CVD risk factors among COVID-19 patients and predict a complicated course.

Cardiovascular risk and fruit and vegetable consumption among women in KSA; A cross-sectional study.

OBJECTIVES: This study aims to assess fruit and vegetable consumption among Saudi women to identify perceived benefits and barriers associated with a healthy diet in cardiovascular disease (CVD) risk prevention and to correlate Framingham risk scores (FRSs) with the perceived barriers. METHODS: A questionnaire adapted from the Health Beliefs Related to Cardiovascular Disease Scale was administered to women attending a primary care centre in KSA. In addition to descriptive statistics, a chi-square test and multiple linear regression analysis were used to determine the association between perceptions of benefit and barriers with FRS categories and between mean FRS and perceived barriers. RESULTS: A total of 503 women were included in this study, and 75% of the women were older than 45 years. More than 60% of women were obese, and 97% consumed 1-3 fruit and vegetable servings per day, whereas only 1.4% consumed fruits and vegetables 5 or more times per day. The majority of women were aware of the benefits of a healthy diet in CVD prevention. No significant difference between FRS and perceived benefits or barriers was observed. Barriers across the low- to high-risk groups included a lack of knowledge about a 'healthy diet', insufficient time to cook, food affordability, and having more important problems. Women who disagreed on barriers had negative beta coefficients for the mean FRS (p < 0.03). CONCLUSIONS: In this study cohort, fruit and vegetable intake was lower than the recommended guidelines. Despite awareness of the benefits of a healthy diet in CVD prevention, very few women understood the true meaning of 'healthy diet'. A direct association between FRS and perceptions/barriers could not be validated. Perceived barriers could be addressed by integrating innovative educational campaigns to existing models of the Healthy Food Plan.

The ticking time bomb in lifestyle-related diseases among women in the Gulf Cooperation Council countries; review of systematic reviews.

BACKGROUND: This study aims to review all published systematic reviews on the prevalence of modifiable cardiovascular disease risk factors among women from the Gulf Cooperation Council countries (GCC). This is the first review of other systematic reviews that concentrates on lifestyle related diseases among women in GCC countries only. METHOD: Literature searches were carried out in three electronic databases for all published systematic reviews on the prevalence of cardiovascular disease risk factors in the GCC countries between January 2000 and February 2016. RESULTS: Eleven systematic reviews were identified and selected for our review. Common reported risk factors for cardiovascular disease were obesity, physical inactivity, diabetes, metabolic syndrome and hypertension. In GCC countries, obesity among the female population ranges from 29 to 45.7%, which is one of the highest rates globally, and it is linked with physical inactivity, ranging from 45 to 98.7%. The prevalence of diabetes is listed as one of the top ten factors globally, and was reported with an average of 21%. Hypertension ranged from 20.9 to 53%. CONCLUSIONS: The high prevalence of lifestyle-related diseases among women population in GCC is a ticking time bomb and is reaching alarming levels, and require a fundamental social and political changes. These findings highlight the need for comprehensive work among the GCC to strengthen the regulatory framework to decrease and control the prevalence of these factors.

Women in Saudi Arabia and the Prevalence of Cardiovascular Risk Factors: A Systematic Review.

Background. Cardiovascular disease (CVD) is one of the leading causes of death in Saudi Arabia. Saudi women in particular are more susceptible as there are sociocultural restrictions on female physical activities that may lead to high prevalence of CVD risks, especially obesity, and physical inactivity. This study aims to systematically review the published articles related to the prevalence of CVD risk among women in Saudi Arabia. The search strategy covers all published articles that assess the risk factor of CVD in Saudi Arabia from January 2000 to December 2015, using the following sources: Medline, Embase, and PsycINFO. A total of 61 studies were included. Results. Prevalence among Saudi women of smoking ranged from 1.1% to 9.1%, hypertension was 21.8%, diabetes ranged from 9.6% to 27.6%, overweight was 27%, and obesity was 40.23%, and physical inactivity ranged from 53.2% to 98.1%. Hypercholesterolemia prevalence on Saudi women on average was 24.5%, while metabolic syndrome ranged from 13.6% to 40.3%. Conclusion. The prevalence of CVD risk factors is high among women in Saudi Arabia especially in obesity and physical inactivity. Public health authorities must implement solutions from a gender specific aspect to reverse the trend and decrease the prevalence of CVDs among Saudi women.

Incidence of adverse drug events in public and private hospitals in Riyadh, Saudi Arabia: the (ADESA) prospective cohort study.

OBJECTIVES: To determine the incidence of adverse drug events (ADEs) and assess their severity and preventability in four Saudi hospitals. DESIGN: Prospective cohort study. SETTING: The study included patients admitted to medical, surgical and intensive care units (ICUs) of four hospitals in Saudi Arabia. These hospitals include a 900-bed tertiary teaching hospital, a 400-bed private hospital, a 1400-bed large government hospital and a 350-bed small government hospital. PARTICIPANTS: All patients (≥12 years) admitted to the study units over 4 months. PRIMARY AND SECONDARY OUTCOME MEASURES: Incidents were collected by pharmacists and reviewed by independent clinicians. Reviewers classified the identified incidents as ADEs, potential ADEs (PADEs) or medication errors and then determined their severity and preventability. RESULTS: We followed 4041 patients from admission to discharge. Of these, 3985 patients had complete data for analysis. The mean±SD age of patients in the analysed cohort was 43.4±19.0 years. A total of 1676 ADEs were identified by pharmacists during the medical chart review. Clinician reviewers accepted 1531 (91.4%) of the incidents identified by the pharmacists (245 ADEs, 677 PADEs and 609 medication errors with low risk of causing harm). The incidence of ADEs was 6.1 (95% CI 5.4 to 6.9) per 100 admissions and 7.9 (95% CI 6.9 to 8.9) per 1000 patient-days. The occurrence of ADEs was most common in ICUs (149 (60.8%)) followed by medical (67 (27.3%)) and surgical (29 (11.8%)) units. In terms of severity, 129 (52.7%) of the ADEs were significant, 91 (37.1%) were serious, 22 (9%) were life-threatening and three (1.2%) were fatal. CONCLUSIONS: We found that ADEs were common in Saudi hospitals, especially in ICUs, causing significant morbidity and mortality. Future studies should focus on investigating the root causes of ADEs at the prescribing stage, and development and testing of interventions to minimise harm from medications.

Incidence of adverse drug events in an academic hospital: a prospective cohort study.

OBJECTIVE: To determine the incidence of adverse drug events (ADEs) and assess their severity and preventability. DESIGN: A prospective cohort study. SETTING: A 900-bed tertiary academic hospital. PARTICIPANTS: A total of 977 patients admitted to two medical, one surgical and two intensive care units over four months. MAIN OUTCOME MEASURES: The primary outcomes were the incidence of ADEs, preventability of ADEs, potential ADEs and medication errors. A physician and a clinical pharmacist independently determined the likelihood that incidents were caused by medications and judged severity and preventability. RESULTS: Pharmacists reviewed the medical records of the 977 patients. Pharmacists identified 361 incidents, of which 281 (78%) were considered to be an ADE, potential ADE or medication error by reviewers. The incidence of ADEs was 8.5 per 100 admissions (95% confidence interval (CI) 6.8-10.4), with the highest rate found in the intensive care unit (21.1 per 100 admissions) (95% CI 15.1-28.8). Of all ADEs, 59% were rated as significant, 35% as serious and 6% as life threatening. Thirty percent of ADEs were preventable and 96% of these occurred in the ordering stage. The incidence of potential ADEs was 13.8 per 100 admissions (95% CI 11.5-16.2). Overall, 223 medication errors were identified, 66 (30%) were harmless, 132 (59%) had the potential to cause harm and 25 (11%) resulted in harm. CONCLUSIONS: The incidence of ADEs in a Saudi Hospital was 8.5 per 100 admissions. Preventable ADEs most commonly occurred in the ordering stage; therefore, interventions to reduce ADEs should target the ordering stage.

Intervention to reduce the use of unsafe abbreviations in a teaching hospital.

OBJECTIVES: To determine the effectiveness of a two-phase intervention designed to reduce the use of unsafe abbreviations. METHODS: An observational prospective study was conducted at the King Khalid University Hospital in Riyadh, Saudi Arabia during May-September 2009. A list of unsafe abbreviations was formulated based on the recommendations of the Institute for Safe Medication Practices. The first 7000 medication orders written at the beginning of each period were collected. Phase one of the intervention involved educating health care professionals about the dangers of using unsafe abbreviations. In the second phase of the intervention, a policy was approved that prohibited the use of unsafe abbreviations hospital-wide. Then, another educational campaign targeted toward prescribers was organized. Descriptive statistics are used in this paper to present the results. RESULTS: At baseline, we identified 1980 medication abbreviations used in 7000 medication orders (28.3%). Three months after phase one of the intervention, the number of abbreviations found in 7000 medication orders had decreased to 1489 (21.3%). Six months later, after phase two of the intervention, the number of abbreviations used had decreased to 710 (10%). During this phase, the use of all abbreviations had declined relative to the baseline and phase one use levels. The decrease in the use of abbreviations was statistically significant in all three periods (P < 0.001). CONCLUSION: The implementation of a complex intervention program reduced the use of unsafe abbreviations by 65%.

Medication error reporting in a university teaching hospital in Saudi Arabia.

OBJECTIVES: Medication errors are common in the hospital setting. Little is known about these errors in Saudi Arabia. The objective of the current study was to explore the rate of reporting medication errors and factors associated with the root causes of these errors in a large tertiary teaching hospital in Saudi Arabia. METHODS: This study was conducted at the university teaching hospital in Riyadh, Saudi Arabia. All occurrence/variant reports related to medication errors were documented on a hospital Web-based medication error form that was designed to capture information on all aspects. Medication error reports were reviewed and reported at quarterly intervals over a 1-year period (November 2009 to October 2010). RESULTS: The medication error rate over the 1-year study period was 0.4% (949 medication errors for 240,000 prescriptions). During this period, 14 (1.5%) errors were categorized as resulting in any harm to the patient (all category E). Medication errors were reported predominantly at the prescribing stage of the medication process (89%). The most common types of errors were prescribing (44%) and improper dose/quantity (31%). Antibiotics (12%), antihypertensive agents (10%), and oral hypoglycemic agents (8%) were the pharmacological classes of medication most commonly involved with errors. Nonspecific performance deficit (43%), knowledge deficit (28%), and illegible or unclear handwriting (17%) were the main reported causes of error. CONCLUSIONS: Medication errors are underreported in a tertiary teaching hospital in Riyadh, Saudi Arabia. Future studies should evaluate the effectiveness of interventions to stimulate medication errors reporting by health-care providers.

Antidepressant use, serotonin transporter affinity, and reinfarction among patients receiving clopidogrel: a population-based study.

PURPOSE: Conflicting evidence exists regarding the association between antidepressant use and reinfarction among high-risk cardiovascular patients. Recent evidence suggests that clinical benefit associated with antidepressants may be related to serotonergic activity, suggesting that some antidepressants may offer greater advantages than others. METHODS: We conducted a population-based nested case-control study among patients aged 66 years or older who commenced clopidogrel between April 1, 2002 and December 31, 2009, following hospital discharge for acute myocardial infarction (AMI). Cases were those who were readmitted for AMI, underwent percutaneous coronary intervention (PCI), or died within 90 days of discharge. Three controls were matched to each case on age, PCI, and the date of hospital discharge. We categorized exposure to antidepressants as current or no use within 120 days before the index date, and the serotonergic activity of antidepressants was further categorized as low, medium, and high according to their affinity for the serotonin transporter. RESULTS: Among 24 090 patients who received clopidogrel following AMI, we identified 2494 cases. Of these, 2444 (98%) were successfully matched to 7045 controls. After extensive multivariable adjustment, antidepressant use was not associated with lower risk of the composite outcome (adjusted odds ratio [OR] 1.11 and 95% confidence interval [CI] 0.98-1.27). The absence of association was consistent across the different antidepressant groups categorized by serotonin transporter affinity. CONCLUSION: In high-risk cardiovascular patients with a history of AMI and treated with clopidogrel, antidepressant use is associated with no additional reduction in risk of reinfarction irrespective of serotonin transporter affinity.

Sodium oxybate for narcolepsy with cataplexy: systematic review and meta-analysis.

STUDY OBJECTIVES: To assess the efficacy and safety of sodium oxybate (SXB) in narcolepsy-cataplexy patients. DESIGN: Systematic review and meta-analysis. PATIENTS: Adults with narcolepsy-cataplexy. INTERVENTIONS: SXB. MEASUREMENTS AND RESULTS: Electronic databases (e.g., MEDLINE) and references of included studies were searched to identify randomized controlled trials (RCTs) assessing the efficacy and safety of SXB for patients with narcolepsy-cataplexy. Risk of bias was appraised using the Cochrane risk of bias tool. Meta-analysis was conducted in Review Manager Version 5. Six RCTs and 5 companion reports were included after screening 14 full-text articles and 483 citations. All were private-industry funded. SXB (usually 9 g/night) was superior to placebo for reducing mean weekly cataplexy attacks (n = 2 RCTs, mean difference [MD]: -8.5, 95% CI: -15.3, -1.6), increasing maintenance wakefulness test (MWT) (n = 2, MD: 5.18, 95% CI: 2.59-7.78), reducing sleep attacks (n = 2, MD: -9.65, 95% CI: -17.72, -1.59), and increasing Clinical Global Impression scores (n = 3, relative risk, RR: 2.42, 95% CI: 1.77-3.32). SXB did not significantly increase REM sleep versus placebo (n = 2, MD: -0.49, 95% CI: -3.90, 2.92). Patients receiving SXB had statistically more adverse events versus placebo, including nausea (n = 3, relative risk [RR]: 7.74, 95% CI: 3.2, 19.2), vomiting (n = 2, RR: 11.8, 95% CI: 1.6, 89.4), and dizziness (n = 3, RR: 4.3, 95% CI: 1.1, 16.4). Enuresis was not significantly different from placebo (n = 2, RR: 2.6, 95% CI: 0.8, 9.8). All meta-analyses had minimal statistical heterogeneity (p-value > 0.1). CONCLUSION: Narcolepsy patients on SXB have significant reductions in cataplexy and daytime sleepiness. SXB is well tolerated in patients with narcolepsy, and most adverse events were mild to moderate in severity.

Knowledge on adherence and safety of the oral contraceptive pill in Saudi women.

OBJECTIVE: To assess knowledge regarding adherence and safety of oral contraceptive pills (OCP) in Saudi women. METHODS: We conducted a cross-sectional prospective study in an outpatient pharmacy at King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia from April to September 2011. Participants were healthy women aged greater than or equal to 18 years with an OCP prescription for contraception. We used a validated questionnaire to assess their knowledge regarding adherence and safety of OCPs. RESULTS: Four hundred and sixty women participated. Most (79%) knew to take an extra pill if they missed one in less than 12 hours, but only 6.5% knew they also had to use extra protection for the next 7 days if it was more than 12 hours. Multiple logistic regression analyses indicated that years of contraceptive use and educational level are predictive factors of better knowledge regarding adherence. Few were aware of the action if they experienced diarrhea for more than 12 hours (10%) or vomiting within 2 hours (13.5%) of taking an OCP. Only 30% knew of the adverse effects of smoking while on OCPs. Weight gain (51%) was the most commonly reported side effect. CONCLUSION: Most Saudi women taking OCPs have limited knowledge of its correct use regarding missing pills, vomiting and diarrhea, and poor awareness of the effects of smoking while using OCPs.

Long-term follow-up of patients with narcolepsy-cataplexy treated with sodium oxybate (Xyrem).

OBJECTIVES: The clinical experience with sodium oxybate (Xyrem) in patients with narcolepsy-cataplexy is still limited, especially in children, elderly patients, and patients with concomitant obstructive sleep apnea (OSA). In this report, we describe 4 patients with narcolepsy and refractory cataplexy who were started on sodium oxybate and followed up for approximately 2 years, including an 11-year-old child and an elderly man with severe OSA. METHODS: The sodium oxybate dose was built up gradually until symptoms were controlled, adverse effects appeared, or the maximum nightly dose of 9.0 g was reached. On average, each subject underwent 4 sleep studies during follow-up after starting sodium oxybate. The nightly dose needed to control symptoms ranged from 5.0 to 9.0 g. RESULTS: Cataplexy, sleep paralysis, and sleep-onset hallucinations disappeared in all cases. In addition, daytime sleepiness decreased subjectively according to the Epworth Sleepiness Scale and objectively according to the Multiple Sleep Latency Test. Polysomnography demonstrated clear reductions in sleep latency, arousal index, and stage 1 sleep (N1). Slow-wave sleep (N3) and sleep efficiency increased with sodium oxybate treatment. Interestingly, the 11-year-old child and the elderly man with documented severe OSA on continuous positive airway pressure therapy demonstrated tolerability to sodium oxybate. Adverse effects included nausea, snoring, paresthesia, convulsion, and enuresis. However, all adverse effects disappeared after reduction of the dose. The beneficial effect of sodium oxybate persisted during the follow-up period. CONCLUSION: Sodium oxybate is an effective and well-tolerated medication for patients with refractory cataplexy. However, it requires special monitoring and follow-up by a specialized center. The improvement in clinical symptoms and sleep architecture seems to persist over time.

Pattern of intravenous proton pump inhibitors use in ICU and Non-ICU setting: a prospective observational study.

BACKGROUND/AIM: The use of intravenous acid-suppressive therapy for stress ulcer prophylaxis in critically ill patients with specific risk factors has been recommended for over a decade. However, there is a lack of supporting data regarding the extension of such therapy to non-critically ill patients (non-ICU). The aim of this study was to compare appropriate indications with current practicing patterns in adult non-ICU and ICU patients, contributing factors and financial impact of inappropriate use. MATERIALS AND METHODS: A prospective cross-sectional study was carried out at a tertiary teaching Hospital in Riyadh, Saudi Arabia. For a period of 4 consecutive months, all hospitalized patients on IV PPI, aged 18 and above, were identified. A concise listing of indications considered appropriate for the use of IV PPI was pre-defined based on material from available literature and guidelines. RESULTS: A total of 255 patients received IV PPI. Inappropriate use of IV PPI was significantly higher in non-ICU (71.7%) than in ICU (19.8%) patients (P=0.01). The most common cause for inappropriate use in non-ICU patients was stress ulcer prophylaxis (SUP). In ICU patients, appropriate indicators for IV PPI were SUP (47.9%), PUD (11.5%), and the UGIB (20.8%). There was a high association between appropriate uses of IV PPI with respect to endoscopic procedure and also between appropriate uses of IV PPI to subsequent discharge with oral PPI in non-ICU patients. The total estimated direct cost (drug acquisition cost) for inappropriate use of IV PPI during the study period was 11,000 US dollars. CONCLUSION: Inappropriate IV PPI utilization was predominant in non-ICU patients, mostly for stress ulcer prophylaxis that leads to a waste of resources. Applying appropriate policies, procedures and evidence-based guidelines, educated physicians and surgeons can clearly limit inappropriate IV PPI use.

Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients.

BACKGROUND: There have been recent reports on the successful use of recombinant factor VIIa (rFVIIa) in non-hemophiliac patients who have experienced heavy blood loss due to trauma with extensive organ damage and who have received multiple blood transfusions with hemostatic changes without success. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and the risk/benefit ratio are still poorly defined. PATIENTS AND METHODS: We conducted a retrospective review of all medical records of patients who received rFVIIa between January 2003 and March 2008. Data collection included demographic characteristics, diagnosis, indications, comorbidities, and amount of blood products used with rFVIIa, dose of rFVIIa, mortality, and adverse events. RESULTS: We identified 45 patients, 27 (60%) males and 18 (40%) females, with a median age of 52 years. The median dose of rFVIIa was 40 microg/kg (range, 20-120 microg/kg). Five (11.1%) patients needed a second dose of rFVIIa (dose range of 20-85 microg/kg) whereas three patients (6.7%) needed a third dose of rFVIIa (dose range of 40-60 microg/kg). There was a marked and significant reduction in transfusion requirements for packed red blood cells (P=.0078). Overall transfusion requirements significantly decreased after the infusion of rFVIIa (P=.0323). Nineteen patients (42.2%) died and thrombosis was documented in 3 patients (6.7%). CONCLUSION: Use of rFVIIa should be based on sound clinical evidence to balance the risks, benefits, and cost if used among non-hemophiliacs. Prospective randomized studies are needed to investigate the efficacy and cost-effectiveness of rFVIIa for this indication and to allow a final assessment of the importance of this treatment.