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1.
Stroke Vasc Neurol ; 7(2): 158-165, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1832554

ABSTRACT

RATIONALE: Haematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth. METHODS AND DESIGN: Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework. HYPOTHESIS: In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo. SAMPLE SIZE ESTIMATES: A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients. INTERVENTION: Participants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo. PRIMARY EFFICACY MEASURE: The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan. DISCUSSION: We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.


Subject(s)
Antifibrinolytic Agents , Stroke , Tranexamic Acid , Antifibrinolytic Agents/adverse effects , Cerebral Hemorrhage/chemically induced , Cerebral Hemorrhage/diagnostic imaging , Cerebral Hemorrhage/drug therapy , Clinical Trials, Phase II as Topic , Hematoma/chemically induced , Hematoma/drug therapy , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Stroke/therapy , Tranexamic Acid/adverse effects
2.
Pol Merkur Lekarski ; 50(296): 118-123, 2022 Apr 19.
Article in English | MEDLINE | ID: covidwho-1790558

ABSTRACT

COVID-19 patients, particularly those with severe pulmonary involvement, are at an increased thromboembolic risk related, among various causes, to the cytokine storm and excessive activation of the coagulation cascade and platelets. Different intensity of anticoagulation for them is proposed, mainly with low molecular weight heparins (LMWHs); in a confirmed pulmonary embolism (PE) the therapeutic dose of LMWH is routinely used. Some authors suggest that hemorrhagic complications in COVID-19 patients are rare. At the same time, one can find reports on internal bleeding, including retroperitoneal hematoma (RPH) and other abdominal hematomas. CASE REPORTS: The authors describe 5 cases (3 of those aged more than 80 years) with giant RPHs and with moderate/severe COVID-19 pneumonia, treated before RPH diagnosis with different enoxaparin doses. The therapeutic dose was given to the male with verified PE limited to the segmental/subsegmental pulmonary arteries and initially to the female in whom echocardiography was strongly suggestive of PE, yet this diagnosis was excluded on CT angiography. In one patient, the enoxaparin dose was escalated from 40 mg bd to 60 mg bd after the D-dimer increase. Two patients had bleeding complications despite the enoxaparin dose restricted to 40 mg/daily or bd. Two males had a coexistent psoas hematoma while in only one female there was a coexistent femoral hematoma. RPHs occurred between day 4 and 14 of hospitalization and all were treated conservatively. Three patients who died were particularly charged, so their deaths were not merely directly associated with RPH, which was closely analyzed in one autopsy performed. The authors underline that the choice of anticoagulation intensity in patients with COVID-19 pneumonia without venous thromboembolism seems sometimes difficult but recent publications indicate the low prophylactic enoxaparin dose as an optimal option. Anticoagulation dose escalation based only on the D-dimer level may not be appropriate for certain patients; moreover, the D-dimer increase is commonly observed during internal bleeding.


Subject(s)
COVID-19 , Pulmonary Embolism , Adult , Aged , Aged, 80 and over , Anticoagulants , COVID-19/complications , Enoxaparin/adverse effects , Enoxaparin/therapeutic use , Female , Hematoma/chemically induced , Hematoma/drug therapy , Heparin, Low-Molecular-Weight/adverse effects , Humans , Male , Middle Aged , Pulmonary Embolism/drug therapy
3.
Ann Med ; 53(1): 295-301, 2021 12.
Article in English | MEDLINE | ID: covidwho-1575822

ABSTRACT

INTRODUCTION: Critically ill patients with COVID-19 are at increased risk of developing a hypercoagulable state due to haemostatic changes directly related to the SARS-CoV-2 infection or to the consequence of the cytokine storm. Anticoagulation is now recommended to reduce the thrombotic risk. Ilio-psoas haematoma (IPH) is a potentially lethal condition that can arise during the hospitalization, especially in intensive care units (ICUs) and frequently reported as a complication of anticoagulation treatment. MATERIALS AND METHODS: We report a case series of seven subjects with SARS-CoV-2 pneumonia complicated by Ilio-psoas haematomas (IPHs) at our COVID-Hospital in Rome, Italy. RESULTS: Over the observation period, 925 subjects with confirmed SARS-CoV-2 infection were admitted to our COVID-hospital. Among them, we found seven spontaneous IPHs with an incidence of 7.6 cases per 1000 hospitalization. All the reported cases had a severe manifestation of COVID-19 pneumonia, with at least one comorbidity and 5/7 were on treatment with low weight molecular heparin for micro or macro pulmonary thrombosis. CONCLUSIONS: Given the indications to prescribe anticoagulant therapy in COVID-19 and the lack of solid evidences on the optimal dose and duration, it is important to be aware of the iliopsoas haematoma as a potentially serious complication in COVID-19 inpatients. KEY MESSAGE Critically ill patients with COVID-19 are at increased risk of hypercoagulability state and anticoagulation therapy is recommended. Ilio-psoas haematoma (IPH) is found to be a complication of anticoagulation regimen especially in severe COVID-19 cases. An incidence of 7.6 cases per 1000 admission of IPHs was reported. Hypoesthesia of the lower limbs, pain triggered by femoral rotation, hypovolaemia and anaemia are the most common symptoms and signs of IPHs that should alert physician.


Subject(s)
Anticoagulants/adverse effects , COVID-19/complications , Hematoma/epidemiology , Psoas Muscles/diagnostic imaging , Thrombophilia/drug therapy , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/drug therapy , COVID-19/virology , Critical Illness/mortality , Critical Illness/therapy , Female , Glucocorticoids/therapeutic use , Hematoma/chemically induced , Hematoma/diagnosis , Hematoma/drug therapy , Heparin, Low-Molecular-Weight , Hospital Mortality , Humans , Incidence , Intensive Care Units , Italy/epidemiology , Magnetic Resonance Imaging , Male , Middle Aged , Muscular Diseases , SARS-CoV-2/isolation & purification , SARS-CoV-2/pathogenicity , Severity of Illness Index , Thrombophilia/etiology , Tomography, X-Ray Computed , Treatment Outcome
4.
Intern Med ; 60(21): 3503-3506, 2021 Nov 01.
Article in English | MEDLINE | ID: covidwho-1572222

ABSTRACT

In hospitalized coronavirus disease 2019 (COVID-19) patients, anticoagulation therapy is administered to prevent thrombosis. However, anticoagulation sometimes causes bleeding complications. We herein report two Japanese cases of severe COVID-19 in which spontaneous muscle hematomas (SMH) developed under therapeutic anticoagulation with unfractionated heparin. Although the activated partial prothrombin time was within the optimal range, contrast-enhanced computed tomography (CECT) revealed SMH in the bilateral iliopsoas muscles in both cases, which required emergent transcatheter embolization. Close monitoring of the coagulation system and the early diagnosis of bleeding complications through CECT are needed in severe COVID-19 patients treated with anticoagulants.


Subject(s)
COVID-19 , Heparin , Anticoagulants/adverse effects , Hematoma/chemically induced , Hematoma/diagnostic imaging , Heparin/adverse effects , Humans , Japan , Muscles , SARS-CoV-2
5.
Cochrane Database Syst Rev ; 6: CD008077, 2021 06 08.
Article in English | MEDLINE | ID: covidwho-1453524

ABSTRACT

BACKGROUND: Heparin is an anticoagulant medication that is usually injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma, and pain at the injection site. One of the factors that may affect pain, haematoma, and bruising is injection speed. Several studies have been carried out to determine if speed of injection affects the amount of pain and bruising where the injection is given; however, the results of these studies have differed, and study authors have not reached a clear final conclusion. This is the second update of a review first published in 2014. OBJECTIVES: To assess the effects of duration (speed) of subcutaneous heparin injection on pain and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). We also looked at haematoma at the injection site. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 June 2020. We undertook reference checking of included studies to identify additional studies. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injection of heparin on pain, bruising, and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: For this update, two review authors independently selected studies and extracted data via Covidence software and assessed methodological quality using Cochrane's risk of bias tool. The primary outcomes of interest were pain intensity at injection site and size and incidence of bruising. The secondary outcomes of interest were size and incidence of haematoma at injection site. We calculated the odds ratio (OR), mean difference (MD), or standardised mean difference (SMD) with corresponding 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria. MAIN RESULTS: We identified one new study for this update, resulting in a total of five included studies with 503 participants who received subcutaneous injections of LMWH into the abdomen. Given the nature of the intervention, it was not possible to blind participants and caregivers (personnel) in any of the included studies. Two studies described blinding of outcome assessors. Overall, the methodological quality of included studies was moderate. The duration of the fast injection was 10 seconds, and the duration of the slow injection was 30 seconds in all included studies. Four studies reported site pain intensity after each injection at different time points. Two studies assessed site pain intensity immediately after each injection; meta-analysis showed no evidence of a difference in site pain intensity immediately after slow injection when compared to fast injection (MD -1.52, 95% CI -3.56 to 0.53; 140 participants; low-certainty evidence). Meta-analysis of three studies indicated that site pain intensity may be slightly reduced 48 hours after the slow heparin injection compared to fast injection (MD -1.60, 95% CI -2.69 to -0.51; 103 participants; low-certainty evidence). Five studies assessed bruise size at 48 hours, and two studies assessed bruise size at 60 hours. Meta-analysis showed there may be a reduction in bruise size 48 hours (SMD -0.54, 95% CI -1.05 to -0.02; 503 participants; 5 studies; very low-certainty evidence) and 60 hours (SMD -0.49, 95% CI -0.93 to -0.06; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. There was no evidence of a difference in bruise size 72 hours after slow injection compared to fast injection (SMD -0.27, 95% CI -0.61 to 0.06; 140 participants; 2 studies; low-certainty evidence). Three studies evaluated incidence of bruising and showed there may be a reduction in bruise incidence 48 hours (OR 0.39, 95% CI 0.26 to 0.60; 444 participants; low-certainty evidence) and 60 hours (OR 0.25, 95% CI 0.10 to 0.65; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. We downgraded the certainty of the evidence due to risk of bias concerns, imprecision, and inconsistency. None of the included studies measured size or incidence of haematoma. AUTHORS' CONCLUSIONS: Administering medication safely and enhancing patient comfort are the main aims of clinical nurses. In this review, we identified five RCTs that evaluated the effect of subcutaneous heparin injection duration on pain intensity, bruise size and incidence. We found that pain may be slightly reduced 48 hours after slow injection. Similarly, there may be a reduction in bruise size and incidence after slow injection compared to fast injection 48 and 60 hours postinjection. We downgraded the certainty of the evidence for all outcomes to low or very low due to risk of bias concerns, imprecision, and inconsistency. Accordingly, new trials with a more robust design, more participants, and a focus on different injection speeds will be useful in strengthening the certainty of the available evidence.


Subject(s)
Anticoagulants/administration & dosage , Contusions/prevention & control , Heparin, Low-Molecular-Weight/administration & dosage , Injections, Subcutaneous/methods , Pain, Procedural/prevention & control , Anticoagulants/adverse effects , Bias , Contusions/chemically induced , Contusions/pathology , Hematoma/chemically induced , Hematoma/pathology , Heparin, Low-Molecular-Weight/adverse effects , Humans , Injections, Subcutaneous/adverse effects , Middle Aged , Pain Measurement/methods , Pain, Procedural/etiology , Randomized Controlled Trials as Topic , Time Factors
6.
Infect Dis (Lond) ; 53(9): 724-729, 2021 09.
Article in English | MEDLINE | ID: covidwho-1211374

ABSTRACT

BACKGROUND: Anticoagulant prophylaxis is part of the standard management of hospitalized COVID-19 patients. Despite adequate thromboprophylaxis, one-third of COVID-19 patients with pneumonia developed pulmonary embolism. This high rate of thrombotic complications has led to higher doses of anticoagulants according to clinical complexity (e.g. intensive care unit (ICU) patients) and D-dimer levels. On the other side of the coin, haemorrhagic complications are being increasingly reported. CASES PRESENTATION: We herein report four cases of spontaneous psoas haematomas (SPH) among 548 patients hospitalized for SARS-CoV-2 pneumonia between March 2020 and January 2021 (incidence of 7.3 cases per 1000 patients). All patients had pneumonia, with age ranging between 62 and 83 years. All patients received anticoagulant therapy with low weight molecular heparin (100 U.I. anti-Xa/kg 2 times/d) from admission: in two cases, a diagnosis of pulmonary embolism was made. In another case, a thrombosis of left axillary and basilic veins was found, and only in one case anticoagulant therapy was started because of elevated levels of D-dimer. In all cases, signs of anaemia were detected and patients experienced low back or abdominal pain. The diagnosis of spontaneous psoas haematoma was made by computed tomography (CT) after a median of 12.5 d (9;16) from admission and 19.5 d (14.75; 24.25) from the beginning of COVID-19 symptoms. Half of these patients died from haemorrhagic shock. CONCLUSIONS: Given the potential life-threatening of SPH and the possible subtle clinical presentation, we believe it is crucial to raise clinicians awareness of this complication among COVID-19 patients undergoing anticoagulants.


Subject(s)
COVID-19 , Venous Thromboembolism , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Hematoma/chemically induced , Hematoma/diagnostic imaging , Humans , Middle Aged , SARS-CoV-2
7.
An Sist Sanit Navar ; 43(2): 251-254, 2020 Aug 31.
Article in Spanish | MEDLINE | ID: covidwho-1080494

ABSTRACT

Infection caused by SARS-CoV-2 (COVID-19) is associated with an increased risk of thromboembolic disease. So-me authors recommend anticoagulation at therapeutic doses for, at least, the most severely ill patients; this practice is not free of risks, which is why only thromboembolic prophylaxis is recommended by other consensuses. In the case of previously anticoagulated patients, changing the oral anticoagulant for a low molecular weight heparin (LMWH) is generally recommended. We present the cases of two patients admitted due to COVID-19, without serious clinical data, in whom anticoagulation (acenocoumarol and rivaroxaban, respectively) was replaced by LMWH at therapeutic doses, both presenting abdominal bleeding. This type of bleeding is an infrequent complication in anticoagulated patients, but the concurrence of two cases in a short period of time in the context of the COVID-19 pandemic leads us to consider that there is not yet any clear evidence on therapeutic anticoagulation in SARS-CoV-2 infection.


Subject(s)
Anticoagulants/adverse effects , Betacoronavirus , Coronavirus Infections/complications , Hematoma/chemically induced , Pneumonia, Viral/complications , Venous Thromboembolism/prevention & control , Venous Thromboembolism/virology , Abdomen , Acenocoumarol/adverse effects , Acenocoumarol/therapeutic use , Aged, 80 and over , Anticoagulants/therapeutic use , COVID-19 , Female , Hematoma/diagnosis , Heparin, Low-Molecular-Weight/adverse effects , Heparin, Low-Molecular-Weight/therapeutic use , Humans , Pandemics , Rivaroxaban/adverse effects , Rivaroxaban/therapeutic use , SARS-CoV-2 , Venous Thromboembolism/drug therapy
8.
S Afr Med J ; 110(12): 1168-1171, 2020 10 08.
Article in English | MEDLINE | ID: covidwho-948164

ABSTRACT

The COVID-19 pandemic has placed significant strain on the oxygen delivery infrastructure of health facilities in resource-constrained health systems. In this case report, we describe a patient with severe COVID-19 pneumonia who was managed with high-flow nasal oxygen for 40 days, with an eventual successful outcome. We discuss the oxygen delivery infrastructure needed to offer this intervention, as well as the psychosocial impact on those undergoing treatment.


Subject(s)
Anticoagulants/therapeutic use , COVID-19/therapy , Glucocorticoids/therapeutic use , Hypoxia/therapy , Oxygen Inhalation Therapy/methods , Oxygen/supply & distribution , Patient Positioning/methods , Psychosocial Support Systems , Anti-Bacterial Agents/therapeutic use , Anxiety/psychology , Anxiety/therapy , Blood Gas Analysis , COVID-19/blood , COVID-19/physiopathology , COVID-19/psychology , Cannula , Citalopram/therapeutic use , Counseling , Dexamethasone/therapeutic use , Disease Progression , Enoxaparin/therapeutic use , Factor Xa Inhibitors/blood , Female , Healthcare-Associated Pneumonia/complications , Healthcare-Associated Pneumonia/diagnosis , Healthcare-Associated Pneumonia/drug therapy , Hematoma/chemically induced , Humans , Hypoxia/blood , Hypoxia/physiopathology , Middle Aged , Oxygen Inhalation Therapy/psychology , Patient Care Team , Patient Positioning/psychology , Piperacillin, Tazobactam Drug Combination/therapeutic use , Prone Position , Psychiatry , Resilience, Psychological , SARS-CoV-2 , Serotonin Uptake Inhibitors/therapeutic use , Severity of Illness Index , Social Work Department, Hospital , Thigh , Treatment Outcome
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