CompletedPhase 4

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

United States94 participantsStarted 2020-05-02

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<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 docum…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU

Timeframe: Discharge from ICU or 30 days

Trial details

NCT IDNCT04367831

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-12

Results submitted2022-05-11

View on ClinicalTrials.gov More COVID-19 trials