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1.
N Engl J Med ; 386(21): 1986-1997, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1864788

ABSTRACT

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).


Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Antifibrinolytic Agents/adverse effects , Antifibrinolytic Agents/therapeutic use , Canada , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Surgical Procedures, Operative , Thrombosis/chemically induced , Thrombosis/drug therapy , Tranexamic Acid/adverse effects , Tranexamic Acid/therapeutic use
2.
Br J Haematol ; 196(2): 351-355, 2022 01.
Article in English | MEDLINE | ID: covidwho-1373796

ABSTRACT

The COVID-19 pandemic has created many challenges in the management of immune thrombocytopenic purpura (ITP). The recommendation for avoidance of steroids by WHO led to the off-licence use, supported by NHS England, of thrombopoietin mimetics (TPO-RA) for newly diagnosed or relapsed ITP. This is a real-world prospective study which investigated the treatment patterns and outcomes in this setting. Twenty-four hospitals across the UK submitted 343 cases. Corticosteroids remain the mainstay of ITP treatment, but TPO-RAs were more effective. Incidental COVID-19 infection was identified in a significant number of patients (9·5%), while 14 cases were thought to be secondary to COVID-19 vaccination.


Subject(s)
COVID-19/epidemiology , Pandemics , Purpura, Thrombocytopenic, Idiopathic/therapy , Adolescent , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Aged, 80 and over , Autoimmune Diseases/complications , COVID-19/blood , COVID-19 Vaccines/adverse effects , Combined Modality Therapy , Comorbidity , Connective Tissue Diseases/complications , Contraindications, Drug , Disease Management , Female , Hemorrhage/epidemiology , Hemorrhage/etiology , Hospitals, District/statistics & numerical data , Humans , Immunoglobulins, Intravenous/therapeutic use , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Neoplasms/complications , Off-Label Use , Platelet Transfusion , Prospective Studies , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Purpura, Thrombocytopenic, Idiopathic/etiology , Tertiary Care Centers/statistics & numerical data , Thromboembolism/epidemiology , Thromboembolism/etiology , Thrombopoietin/agonists , Tranexamic Acid/therapeutic use , Treatment Outcome , United Kingdom/epidemiology , Young Adult
6.
BMJ Open ; 11(1): e040273, 2021 01 17.
Article in English | MEDLINE | ID: covidwho-1032967

ABSTRACT

INTRODUCTION: Blood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients. METHODS AND ANALYSIS: The HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned. ETHICS AND DISSEMINATION: The HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF. TRIAL REGISTRATION NUMBER: clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.


Subject(s)
Anemia/drug therapy , Blood Transfusion/statistics & numerical data , Hip Fractures/surgery , Iron/therapeutic use , Tranexamic Acid/therapeutic use , Administration, Intravenous , Antifibrinolytic Agents/therapeutic use , Blood Loss, Surgical/prevention & control , Clinical Trials, Phase III as Topic , Double-Blind Method , France , Hemoglobins/analysis , Hip Fractures/complications , Humans , Multicenter Studies as Topic , Preoperative Care/methods , Randomized Controlled Trials as Topic , Treatment Outcome
7.
Anaesth Crit Care Pain Med ; 39(3): 351-353, 2020 06.
Article in English | MEDLINE | ID: covidwho-986871
8.
BMJ Case Rep ; 13(9)2020 Sep 09.
Article in English | MEDLINE | ID: covidwho-760235

ABSTRACT

SARS-CoV-2, the virus responsible for COVID-19, binds to the ACE2 receptors. ACE2 is thought to counterbalance ACE in the renin-angiotensin system. While presently it is advised that patients should continue to use ACE inhibitors or angiotensin receptor blockers, questions still remain as to whether adverse effects are potentiated by the virus. Here, we report a case of a 57-year-old man, unknowingly with COVID-19, who presented to the emergency department with tongue swelling, shortness of breath and difficulty in speaking following 4 months taking benazepril, an ACE inhibitor. Finally, we also describe possible pathways that exist for SARS-CoV-2 to interact with the mechanism behind angioedema.


Subject(s)
Angioedema/chemically induced , Angioedema/complications , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Benzazepines/adverse effects , Betacoronavirus , Coronavirus Infections/complications , Pneumonia, Viral/complications , Angioedema/drug therapy , Anti-Allergic Agents/therapeutic use , COVID-19 , Diagnosis, Differential , Diphenhydramine/therapeutic use , Famotidine/therapeutic use , Histamine H2 Antagonists/therapeutic use , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2 , Tranexamic Acid/therapeutic use
10.
BMC Pregnancy Childbirth ; 20(1): 481, 2020 Aug 24.
Article in English | MEDLINE | ID: covidwho-727268

ABSTRACT

BACKGROUND: The world's understanding of COVID-19 continues to evolve as the scientific community discovers unique presentations of this disease. This case report depicts an unexpected intraoperative coagulopathy during a cesarean section in an otherwise asymptomatic patient who was later found to have COVID-19. This case suggests that there may be a higher risk for intrapartum bleeding in the pregnant, largely asymptomatic COVID-positive patient with more abnormal COVID laboratory values. CASE: The case patient displayed D-Dimer elevations beyond what is typically observed among this hospital's COVID-positive peripartum population and displayed significantly more oozing than expected intraoperatively, despite normal prothrombin time, international normalized ratio, fibrinogen, and platelets. CONCLUSION: There is little published evidence on the association between D-Dimer and coagulopathy among the pregnant population infected with SARS-CoV-2. This case report contributes to the growing body of evidence on the effects of COVID-19 in pregnancy. A clinical picture concerning for intraoperative coagulopathy may be associated with SARS-CoV-2 infection during cesarean sections, and abnormal COVID laboratory tests, particularly D-Dimer, may help identify the patients in which this presentation occurs.


Subject(s)
Blood Coagulation Disorders/blood , Blood Loss, Surgical , Breech Presentation/surgery , Cesarean Section , Coronavirus Infections/blood , Pneumonia, Viral/blood , Pregnancy Complications, Hematologic/blood , Pregnancy Complications, Infectious/blood , Adult , Antifibrinolytic Agents/therapeutic use , Betacoronavirus , Blood Coagulation Disorders/drug therapy , Blood Coagulation Disorders/metabolism , C-Reactive Protein/metabolism , COVID-19 , Cautery , Coronavirus Infections/diagnosis , Coronavirus Infections/metabolism , Female , Fibrin Fibrinogen Degradation Products/metabolism , Fibrinogen/metabolism , Hemostasis, Surgical , Humans , International Normalized Ratio , Methylergonovine/therapeutic use , Oligohydramnios , Oxytocics/therapeutic use , Oxytocin/therapeutic use , Pandemics , Platelet Count , Pneumonia, Viral/diagnosis , Pneumonia, Viral/metabolism , Pregnancy , Pregnancy Complications, Hematologic/drug therapy , Pregnancy Complications, Hematologic/metabolism , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/metabolism , Prothrombin Time , SARS-CoV-2 , Tranexamic Acid/therapeutic use , Uterine Inertia/drug therapy
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