zero-hep: Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation
Study Details
Study Description
Brief Summary
The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. No heparinization (Zero-Hep) will be compared to standard low-dose heparinization (Standard). Traditionally, the Vienna group has used a standard low-dose heparin protocol with unfractionated heparin (UFH) administered as a bolus upon ECMO cannulation. With heparin-coated tubing and intraoperative ECMO flow never falling below 1 L/min, the likelihood of thromboembolic events is believed to be negligible. To date, the investigators have not experienced any thromboembolic events during intra-operative ECMO use. On the other hand, the use of UFH entails an increased risk for bleeding, so it follows that avoidance of additional heparin may be beneficial. Generally, risks and benefits of heparinization during these short procedures have not yet been thoroughly analyzed. This study will investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response comparing 40 patients receiving a standard dose of heparin versus 40 patients receiving placebo in a randomized, double-blind study design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Saline 0.9% |
Drug: Placebo
Lung transplantation on central veno-arterial ECMO without additional heparin
|
| Active Comparator: Heparin sodium 70 international units (IU)/kg Heparin sodium |
Drug: Heparin sodium
Lung transplantation on central veno-arterial ECMO with standard additional heparin
|
Outcome Measures
Primary Outcome Measures
- Arterial thromboembolic events [From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant]
Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack
- Venous thromboembolic events [From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant]
deep vein thrombosis, pulmonary embolism, cerebral venous or cavernous sinus thrombosis
- Circuit-related thrombosis [From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation]
requiring ECMO oxygenator exchange
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Double lung transplantation
-
Age of 18 or older at the time of the procedure
Exclusion Criteria:
-
Single lung transplantation
-
Re-transplantation
-
Previous major thoracic surgery (excluding pleural drainage, video-assisted thoracoscopic - (VATS) biopsy)
-
ECMO bridge to transplantation
-
Coronavirus(COVID) - acute respiratory distress syndrome (ARDS) as transplant indication
-
Pre-operative anti-coagulation/anti-platelet treatment
-
Paediatric transplantation
-
Multi-organ transplantation
-
Active pregnancy or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna - Dept. of Thoracic Surgery | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Konrad Hoetzenecker, MD PhD, Medical University of Vienna - Dept. of Thoracic Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2128/2021