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

INTERVENTION: 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: equal Concentration number: 5000‐ Pharmaceutical form of the placebo: Injection/infusion Route of administration of the placebo: Intravenous use CONDITION: Intraoperative extra‐corporeal membrane oxygenation during lung transplantation for end‐stage lung disease Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: 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 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); Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital SECONDARY OUTCOME: 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 Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital 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