Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transpla… (NCT06868823) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
Czechia40 participantsStarted 2025-05-01
Plain-language summary
The aim of this observational pilot study is to evaluate the effectiveness and safety of low-molecular-weight heparin (LMWH) compared to unfractionated heparin (UFH) as anticoagulation in perioperative ECMO during bilateral lung transplantation.
The main question this study seeks to answer is:
Does LMWH provide a safe and effective alternative to UFH for ECMO anticoagulation in lung transplantation, with reduced bleeding and thrombotic complications?
Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support will be assigned to one of two anticoagulation strategies:
UFH group: Standard UFH anticoagulation monitored using ROTEM. LMWH group: Enoxaparin-based anticoagulation monitored using ROTEM. The study will assess perioperative blood loss, hemoglobin levels, transfusion needs, and thrombotic events. Additional analyses will include coagulation profile assessments using point-of-care (POC) tests, thrombin generation test (TGT), and laboratory coagulation parameters.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. ⃣ Planned perioperative anticoagulation with either UFH or LMWH, as determined by the attending anesthesiologist.
. ⃣ Ability to provide informed consent or consent provided by a legally authorized representative.
Exclusion criteria
. ⃣ Patients receiving ECMO as a bridge to lung transplantation.
. ⃣ Patients requiring postoperative continuation of ECMO.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perioperative Blood Loss
Timeframe: Measured intraoperatively, at the end of surgery.
2
Change in Hemoglobin Levels during surgery and within 24 hours after surgery
Timeframe: Intraoperative: Change in hemoglobin from preoperative levels to the end of surgery. Postoperative: Change in hemoglobin from preoperative levels to 24 hours post-surgery.
3
Blood Transfusion Requirements during surgery and Within 24 Hours after surgery
Timeframe: Intraoperative: PRBC transfusions administered during surgery. Postoperative: PRBC transfusions administered within the first 24 hours after surgery.
4
Incidence of Thrombotic Complications during surhery and within 24 Hours postoperatively.
Timeframe: Intraoperative: Thrombotic events occurring during surgery. Postoperative: Thrombotic events occurring within 24 hours after surgery.