Recombinant factor VIIa restores aggregation of alphaIIbbeta3-deficient platelets via tissue factor-independent fibrin generation.
Ton Lisman, Jelle Adelmeijer, Harry F G Heijnen...
https://pubmed.ncbi.nlm.nih.gov/14592825Actively Recruiting
Age: 18Years +
All Genders
ID06868823
LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study
Led by University Hospital, Motol · Updated on 2025-06-10
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of low-molecular-weight heparin (LMWH) versus unfractionated heparin (UFH) for anticoagulation during perioperative veno-arterial extracorporeal membrane oxygenation (ECMO) support in patients undergoing bilateral lung transplantation. The study explores whether LMWH can reduce bleeding and thrombotic complications compared to the standard UFH treatment. This pilot observational study involves 40 patients divided into two groups receiving either LMWH or UFH anticoagulation strategies. Participants assigned to the UFH group receive a bolus of 20-40 IU/kg UFH 30 minutes before ECMO starts, followed by a continuous infusion. The LMWH group receives a similar bolus and infusion of Enoxaparin-based LMWH. Both groups have their coagulation monitored in real time using ROTEM tests and undergo standard laboratory and point-of-care coagulation assessments. In cases of significant blood loss, a detailed bleeding management protocol including administration of recombinant activated factor VIIa and other blood products is initiated. During the study, patients are closely evaluated for perioperative blood loss, changes in hemoglobin levels, blood transfusion requirements, and thrombotic events both during surgery and within 24 hours afterward. Additional coagulation profiles are assessed using thrombin generation tests and various laboratory parameters at multiple timepoints. The study ensures informed consent and careful monitoring to assess the comparative safety and effectiveness of the two anticoagulation methods over the perioperative period.
CONDITIONS
Brief Title
Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Undergoing bilateral lung transplantation with perioperative veno-arterial ECMO support
- Planned perioperative anticoagulation with either UFH or LMWH as decided by the anesthesiologist
- Able to provide informed consent or have consent given by a legal representative
You will not qualify if you...
- Receiving ECMO as a bridge to lung transplantation
- Requiring postoperative continuation of ECMO
- Experiencing perioperative blood loss of 3000 mL or more
- Undergoing lung re-transplantation
- History of severe coagulopathy or bleeding disorder
- Active use of antiplatelet or anticoagulant therapy (except study anticoagulants)
- Known heparin-induced thrombocytopenia (HIT)
- Severe liver dysfunction (Child-Pugh C) or end-stage renal disease requiring dialysis
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Perioperative period including surgery and immediate postoperative time (typically a few days)
Participants undergo bilateral lung transplantation with perioperative veno-arterial ECMO support and receive anticoagulation with either LMWH or UFH. Anticoagulation is administered starting 30 minutes before ECMO initiation and continued throughout the perioperative period, with real-time coagulation monitoring using ROTEM and standard laboratory tests.
1 hospital stay including surgery and perioperative care
Post-operative Follow-up
Duration - 24 hours after surgery
Participants are monitored for bleeding, thrombotic complications, and coagulation profiles through blood tests and clinical assessments up to 24 hours after surgery, including management of any bleeding events per protocol.
Assessments during hospital stay post-surgery
Trial Site Locations
Total: 1 location
1
University Hospital Motol, 2nd Faculty of Medicine, Charles University in Prague and 3rd Department of Surgery, First Faculty of Medicine, Charles University, and Motol University Hospital, Lung Transplant Program
Prague, Czech Republic, Czechia, 150 06
Actively Recruiting
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Research Team
M
Miroslav Durila, prof. M.D., Ph.D., MHA
G
Gabriela Holubova, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Jason Brase, Brooke Finger, Jianghua He...
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Z Xiao, P Théroux
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J K Burgess, B H Chong
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A A Ajayi, F B Pharmacols, J Cooper...
https://pubmed.ncbi.nlm.nih.gov/18040530Intravenous enoxaparin guided by anti-Xa in venovenous extracorporeal membrane oxygenation: A retrospective, single-center study.
Miroslav Durila, Jaromir Vajter, Michal Garaj...
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Khaled A Yassen, Emad K Refaat, Safaa M Helal...
https://pubmed.ncbi.nlm.nih.gov/37564856Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study).
Jean-Christophe Rigal, Elodie Boissier, Karim Lakhal...
https://pubmed.ncbi.nlm.nih.gov/31694845Determination of enoxaparin with rotational thrombelastometry using the prothrombinase-induced clotting time reagent.
Eva Schaden, Andreas Schober, Stefan Hacker...
https://pubmed.ncbi.nlm.nih.gov/20087172Reappearance of circulating heparin in whole blood heparin concentration-based management does not correlate with postoperative bleeding after cardiac surgery.
Junko Ichikawa, Mitsuharu Kodaka, Keiko Nishiyama...
https://pubmed.ncbi.nlm.nih.gov/24508375