At a glance
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Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID)
In Brief
A Phase 4 clinical trial evaluating Enoxaparin Prophylactic Dose, Heparin Infusion, and 2 other interventions for COVID-19 and 2 related conditions. Completed, enrolled 94 participants across 1 site.
Detailed Summary
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Study Details
Timeline
Interventions
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines): If eGFR ≥30 mL/min (stable kidney function): 1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily 2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h 3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.