Status:
COMPLETED
Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19
Lead Sponsor:
Columbia University
Conditions:
COVID-19
Venous Thromboses
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 u...
Detailed Description
Hemostatic, biomarker, and inflammatory changes are common in severe manifestations of coronavirus disease 2019 (COVID-19).Such factors, as well as the bedridden status and critical illness may consti...
Eligibility Criteria
Inclusion
- 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
- Weight under 50kg
- Contraindication to anticoagulation in the opinion of the treating clinician including
- overt bleeding
- platelet count \<50,000
- Bleeding Academic Research Consortium (BARC) major bleeding in the past 30 days
- Gastrointestinal (GI) bleeding within 3 months
- history of intracranial hemorrhage
- Ischemic stroke within the past 2 weeks
- craniotomy/major neurosurgery within the past 30 days
- cardiothoracic surgery within the past 30 days
- intra-abdominal surgery within 30 days prior to enrollment
- Head or spinal trauma in the last months
- History of uncorrected cerebral aneurysm or arteriovenous malformation (AVM)
- Intracranial malignancy
- Presence of an epidural or spinal catheter
- Recent major surgery within the last 14 days
- Decrease in hemoglobin \>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.
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04367831
Start Date
May 2 2020
End Date
May 12 2021
Last Update
December 10 2024
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032