Phase 4 N=94 Randomized Single-blind Treatment

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

COVID-19 · Venous Thromboses · Arterial Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT04367831 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU — 28; 31 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Enoxaparin Prophylactic Dose (Drug); Heparin Infusion (Drug); Heparin SC (Drug); Enoxaparin/Lovenox Intermediate Dose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU	28; 31	—
SECONDARY Total Number of Patients With Clinically Relevant Venous or Arterial Thrombotic Events in ICU	15; 18	—
SECONDARY ICU Length of Stay	23; 26	—
SECONDARY Total Number of Patients With the Need for Renal Replacement Therapy in the ICU	11; 15	—
SECONDARY Total Number of Patients With Major Bleeding in the ICU	5; 5	—
SECONDARY Hospital Length of Stay	17.78; 17.73	—

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.

Eligibility Criteria

Inclusion Criteria

Confirmed diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)
New admission to eligible CUIMC ICUs within 5 days
Transfer from nonparticipating to participating ICU is eligible if otherwise meets eligibility criteria.
Patients transferred between participating ICUs will maintain initial treatment assignment.
Patients not on therapeutic anticoagulation and who were already admitted to participating ICU within 5 days of trial initiation are additionally eligible.

Exclusion Criteria

Weight under 50kg
Contraindication to anticoagulation in the opinion of the treating clinician including
overt bleeding
platelet count 3 g/dL over the last 24 hours
Allergic reaction to anticoagulants (e.g. Heparin Induced Thrombocytopenia) as documented in the electronic health records. Extracorporeal membrane oxygenation (ECMO) support or other mechanical circulatory support.
Severe chronic liver dysfunction (history of portosystemic hypertension (HTN), esophageal varices, or Child-Pugh class C or above or similar Model For End-Stage Liver Disease (MELD) scores), abnormality in liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin) 5 times greater than upper normal limit.
A history of congenital bleeding diatheses or anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia)
Treating physician preference for therapeutic anticoagulation
Enrollment in other concurrent trials related to anticoagulant or antiplatelet therapy
Existing treatment with therapeutic anticoagulation during the previous 7 days of hospitalization prior to ICU admission (e.g. for venous thromboembolism (VTE), atrial fibrillation, mechanical valve, etc).
Do-not-resuscitate (DNR) /do-not-intubate (DNI) or comfort measures only (CMO) orders prior to randomization.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04367831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.