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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 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.

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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.

Interventions

  • OTHER Low intensity anticoagulation
  • OTHER Moderate Intensity Anticoagulation

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2022-05-12
Est. Completion 2024-01-10
Phase NA

What the Registry Record Tells You About NCT04997265

The ClinicalTrials.gov registry entry for NCT04997265 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 312-participant average among 8 other Thromboembolism trials with a reported enrollment target (92% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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