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Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19

NCT04367831 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-12-10

Study results available
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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.

Conditions

  • COVID-19
  • Venous Thromboses
  • Arterial Thrombosis

Interventions

DRUG

Enoxaparin Prophylactic Dose

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

DRUG

Heparin Infusion

Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.

DRUG

Heparin SC

Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.

DRUG

Enoxaparin/Lovenox Intermediate Dose

If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.

Sponsors & Collaborators

Principal Investigators

  • Ajay Kirtane, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-02
Primary Completion
2021-05-12
Completion
2021-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367831 on ClinicalTrials.gov