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Anticoagulant

Anticoagulation Strategies for Respiratory Insufficiency (SAFE-ECMO Trial)

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Presence of an indication for systemic anticoagulation: Ongoing receipt of systemic anticoagulation

Patient is < 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of low and moderate intensity anticoagulation on clinical outcomes during V-V ECMO.

Who is the study for?

This trial is for adults on venovenous ECMO at Vanderbilt University Medical Center without severe bleeding disorders, low platelets, recent major surgery or trauma, heparin allergy, active COVID-19 infection, or conditions that require a specific anticoagulation approach.

What is being tested?

The study compares two anticoagulation strategies in patients using V-V ECMO: a fixed low intensity dose versus a variable moderate intensity dose to see which one leads to better clinical outcomes and fewer complications.

What are the potential side effects?

Potential side effects include increased risk of bleeding with both anticoagulation methods. Low intensity may raise the chance of blood clots while moderate intensity might lead to more significant bleeding events.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on blood thinners.

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I am under 18 years old.

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I have not had major surgery or serious injury within the last 3 days.

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I have a known bleeding disorder.

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I have a condition that makes blood thinners unsafe due to active bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of major bleeding events

Frequency of thromboembolic events

Secondary study objectives

Bleeding events from randomization to the first of death or discharge

Bleeding events per ECMO day

Death attributable to a major bleeding event

+15 more

Other study objectives

Duration of the intervention period (days)

Hours receiving low intensity or moderate intensity anticoagulation

Number of and specific reasons for "missed" enrollments

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low Intensity AnticoagulationExperimental Treatment1 Intervention

For patients assigned to the low intensity anticoagulation strategy, clinical teams will be instructed to initiate low intensity anticoagulation at doses and frequencies commonly used for deep vein thrombosis (DVT) prophylaxis. The choice of anticoagulant, dose, and frequency of administration will be deferred to treating clinicians.

Group II: Moderate Intensity AnticoagulationActive Control1 Intervention

For patients assigned to the moderate intensity anticoagulation group, clinical teams will be instructed to initiate a continuous infusion of moderate intensity anticoagulation targeting either a partial thromboplastin time (PTT) of 40-60 seconds or an Anti-Xa level of 0.2 to 0.3 IU/mL. The choice of anticoagulant and approach to dosing will be deferred to treating clinicians.

0 / 5Eligibility criteria met