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NCT04997265 · ClinicalTrials.gov registry record · NA
Strategies for Anticoagulation During Venovenous ECMO
A NA study of Thromboembolism and Acute Hypoxemic Respiratory Failure, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT04997265: Completed NA study of Thromboembolism and Acute Hypoxemic Respiratory Failure, sponsored by Vanderbilt University Medical Center.
NCT04997265 is a NA study of Thromboembolism and Acute Hypoxemic Respiratory Failure that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 26 participants, below the 312-participant average among 8 other Thromboembolism trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04997265, a NA study of Thromboembolism and Acute Hypoxemic Respiratory Failure, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has decreased, leading to re-evaluation of the risks of anticoagulation, particularly during venovenous (V-V) ECMO. Recent data suggest that bleeding complications during V-V ECMO may be more strongly associated with mortality than thromboembolic complications, and case series have suggested that V-V ECMO can be safely performed without moderate or high intensity anticoagulation. At present, there is significant variability between institutions in the approach to anticoagulation during V-V ECMO. A definitive randomized controlled trial is needed to compare the effects of a low intensity fixed dose anticoagulation (low intensity) versus moderate intensity titrated dose anticoagulation (moderate intensity) on clinical outcomes during V-V ECMO. Before such a trial can be conducted, however, additional data are needed to inform the feasibility of the future trial.
Primary Outcome
Major bleeding event, according to the International Society on Thrombosis and Hemostasis, defined as: 1. Fatal bleeding 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome 3. Clinically overt bleeding associated with either a drop in hemoglobin level by at least 2.0 grams/dL or leading to transfusion of two or more units of packed red blood cells
Conditions Studied
Interventions
- OTHER Low intensity anticoagulation
- OTHER Moderate Intensity Anticoagulation
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2024-01-10 |
| Phase | NA |
What the finished NCT04997265 record still lists
NCT04997265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 312-participant average among 8 other Thromboembolism trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Thromboembolism appearing as the primary indexed condition, and to 2 interventions - of which Low intensity anticoagulation is the first listed.
NCT04997265 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04997265 about?
NCT04997265 is a clinical study titled "Strategies for Anticoagulation During Venovenous ECMO". Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has decreased, leading to re...
What is the current status of trial NCT04997265?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2022-05-12. Estimated completion is 2024-01-10.
What conditions does trial NCT04997265 study?
This clinical trial studies the following conditions: Thromboembolism, Acute Hypoxemic Respiratory Failure, Anticoagulant-Induced Bleeding.
What interventions are being tested in trial NCT04997265?
The interventions under investigation include: Low intensity anticoagulation (OTHER), Moderate Intensity Anticoagulation (OTHER).
Who is sponsoring clinical trial NCT04997265?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04997265 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04997265's enrollment target sits among peer trials
26 9th of 8 the lowest of 8 other Thromboembolism trials
participants (enrollment target), bucketed by value
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