ow-dose heparin in critically ill patients undergoing extracorporeal membrane oxygenation – Feasibility study

Phase 1

• Conditions: critically ill patients undergoing extracorporeal membrane oxygenation; Blood - Clotting disorders

• Registration Number: ACTRN12613001324707
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

patients hospitalised in intensive care unit who require ECMO or on ECMO for less than 48 hours.

Exclusion Criteria

Age younger than 16 years
Pregnancy
Known objection to the administration of human blood products
Participation in a competing study on anticoagulation
Heparin-induced thrombocytopenia
Any pre-existing indication for prolonged full dose anti-coagulation: long-term warfarin for atrial fibrillation), pulmonary emboli, deep venous thrombosis, intra-cardiac thrombus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoints for feasibility: <br>Difference in the mean daily dose of heparin between both study groups<br><br>[At the end of extra corporeal membrane oxygenation course];Primary Endpoints for safety:<br>Incidence of ECMO circuit thrombosis requiring circuit change<br>Incidence of new major systemic thromboembolic events defined as stroke, limb ischemia related to intravascular[At the end of extra corporeal membrane oxygenation course];Difference in the mean APTT and the mean anti-Xa between both study groups thrombosis or emboli or intra-cardiac thrombus[at the end of the ECMO course]

Secondary Outcome Measures

Name	Time	Method
umber of RBC administered per ECMO day <br>[At ECMO ceased, ICU discharge and hospital discharge];Number of days on the bleeding management protocol <br>[end of ECMO course];Bleeding events defined by a bleeding associated with either a drop in haemoglobin concentration by 20 g/L or a transfusion of at least 2 units of packed red blood cells/24 hours<br>[until the end of ECMO course];ICU and Hospital mortality<br>[ICU and Hospital discharge];ICU and Hospital length of stay[ICU and hospital discharge];New pulmonary emboli and deep vein thrombosis [ICU discharge];Number of blood product transfused (Red Blood cells, fresh frozen plasma, Platelets) during the ICU stay and after randomisation[ICU discharge];Number of blood stream infection diagnosed post randomisation in ICU<br>[ICU discharge]