An investigation of heart-lung support without blood thinners during lung transplantation

An investigation of clinical outcomes and inflammatory response to heparin free extracorporeal membrane oxygenation support during clinical lung transplantation – a prospective double-blind randomised feasibility study - zero-hep

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001697-58-AT

Enrollment

Registered

2022-12-02

Start date

2022-12-20

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative extra-corporeal membrane oxygenation during lung transplantation for end-stage lung disease

Interventions

Trade Name: Heparin Gilvasan Pharmaceutical Form: Injection/infusion INN or Proposed INN: Heparin CAS Number: 9041-08-1 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult recipients over the age of 18 at the time of the procedure, receiving a double lung transplantation (including lungs after ex-vivo lung perfusion) within the Vienna Lung Transplant Program who have given informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Single lung transplantation. Re-transplantation. Previous major thoracic surgery (excluding pleural drainage, VATS biopsy). ECMO bridge to transplantation. COVID-ARDS as transplant indication. Pre-operative anti-coagulation/anti-platelet treatment. Paediatric transplantation. Multi-organ transplantation. Active pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response;Secondary Objective: Not applicable;Primary end point(s): comparison of the thromboembolic events defined as primary study endpoints (arterial, venous thromboembolic events, circuit-related thrombosis) • Arterial thromboembolic events: myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack • Venous thromboembolic events: deep vein thrombosis, pulmonary embolism, cebrebral venous or cavernous sinus thrombosis • Circuit-related thrombosis (requiring ECMO oxygenator exchange) ;Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital	—

Measure

Time frame

Main Objective: To investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response;Secondary Objective: Not applicable;Primary end point(s): comparison of the thromboembolic events defined as primary study endpoints (arterial, venous thromboembolic events, circuit-related thrombosis) • Arterial thromboembolic events: myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack • Venous thromboembolic events: deep vein thrombosis, pulmonary embolism, cebrebral venous or cavernous sinus thrombosis • Circuit-related thrombosis (requiring ECMO oxygenator exchange) ;Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital;Secondary end point(s): Secondary study endpoints (serious bleeding, in-house mortality rate) as well as other secondary outcomes (Transfusion products in the first 24 hours after ECMO cannulation (red blood cells (RBCs), platelets (Plts), fresh frozen plasma (FFP), cryopercipitate (Cryo), factor VII)), Inflammatory burden signified by perfusate protein marker levels	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital;Secondary end point(s): Secondary study endpoints (serious bleeding, in-house mortality rate) as well as other secondary outcomes (Transfusion products in the first 24 hours after ECMO cannulation (red blood cells (RBCs), platelets (Plts), fresh frozen plasma (FFP), cryopercipitate (Cryo), factor VII)), Inflammatory burden signified by perfusate protein marker levels

—

Countries

Austria

Contacts

Public ContactPrincipal Investigator

Medical University of Vienna

004314040056440

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026