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Compares treatment options for Extracorporeal Membrane Oxygenation Complication
Official title BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
ClinicalTrials.gov ID: NCT05959252
What this study is testing
What is Unfractionated heparin?
Unfractionated heparin is an investigational medicine, being studied as a potential treatment for extracorporeal membrane oxygenation complication.
Also referred to as Heparin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support. The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients receiving ECMO
- Age: 18 years or older
- Ability to randomise the patient within 4 hours of ECMO support initiation
You likely can't join if
- Post-cardiotomy ECMO patients
- Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
- Heparin induced thrombotic thrombocytopenia syndrome
- Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
- Limitations of care put in place either through patient wishes or the treating medical teams
- Other reason where the treating physician deems the study is not in the patient's best interest
See the full eligibility criteria
- Patients receiving ECMO
- Age: 18 years or older
- Ability to randomise the patient within 4 hours of ECMO support initiation
- Post-cardiotomy ECMO patients
- Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
- Heparin induced thrombotic thrombocytopenia syndrome
- Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
- Limitations of care put in place either through patient wishes or the treating medical teams
- Other reason where the treating physician deems the study is not in the patient's best interest
- Patients who are suspected or confirmed to be pregnant
- Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.