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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
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
SAFE-ECMO Trial 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.Check my eligibility
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.See study design
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.
SAFE-ECMO Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of major bleeding events
Frequency of thromboembolic events
Secondary outcome measures
Bleeding events from randomization to the first of death or discharge
Bleeding events per ECMO day
Death attributable to a major bleeding event
+15 moreOther outcome measures
Duration of the intervention period (days)
Hours receiving low intensity or moderate intensity anticoagulation
Number of and specific reasons for "missed" enrollments
+6 moreSAFE-ECMO 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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,162 Total Patients Enrolled
Jonathan D Casey, MD, MScStudy DirectorVanderbilt University Medical Center
4 Previous Clinical Trials
5,145 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to heparin.You are currently receiving V-V ECMO treatment.I am currently on blood thinners.You have had a condition called heparin-induced thrombocytopenia.You had a procedure called ECMO cannulation more than 24 hours before the screening.I am scheduled to receive blood thinners for a reason other than ECMO.I am under 18 years old.I have not had major surgery or serious injury within the last 3 days.I tested positive for COVID-19 in the last 21 days or my doctor strongly suspects I have it.My doctor says I need special blood clot management during my ECMO treatment.I have a known bleeding disorder.You currently have a very low platelet count, less than 30,000.You have an arterial ECMO cannula or plan to have one inserted.I have a condition that makes blood thinners unsafe due to active bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Low Intensity Anticoagulation
- Group 2: Moderate Intensity Anticoagulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open positions in this clinical trial?
"As per the clinicaltrials.gov database, this medical trial is open for enrollment and was posted on May 12th 2022 before being updated a few days later."
Answered by AI
What primary aims are being pursued with this trial?
"This investigation's primary outcome is the frequency of thromboembolic events measured from randomization to death or decannulation 24 hours later, up until study completion which usually takes 2 years. Secondary objectives encompass evaluating the number of thromboembolic incidents between randomization and either death or hospital release in 100 months, calculating for hospital-free days within 28 days after randomisation, as well as ascertaining peak total and indirect bilirubin values during clinical visits."
Answered by AI
What is the current enrollment quota for this research endeavor?
"Correct. Clinicaltrials.gov indicates that this clinical trial launched on May 12th 2022 and is still actively recruiting participants, with the most recent update being dated May 15th 2022. The study requires only 15 individuals to be recruited from a single site."
Answered by AI
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