None listed
Conditions
Brief summary
Extra corporeal membrane oxygenation (ECMO) in intensive care unit (ICU) is a rescue therapy for reversible cardiac and/or respiratory failures. It can also provide support until cardiac or lung transplantation. Haemorrhagic complications are the most frequent of the complications occurring on ECMO, and they have been shown to independently impact on patients’ prognosis. Although some of the haemorrhagic complications may be related to patient severity or patient disease, improving anticoagulation management may prevent some bleeding events and improve patient outcome. The primary aim of this study is to determine the feasibility of administrating low dose anti coagulation in critically ill patients on ECMO when there is no indication for full systemic anticoagulation We will randomise 20 patients so that 10 will receive low dose heparin and compare their complications and outcomes to the other 10 patients treated with the standard dose of heparin.
Interventions
Critically ill patients undergoing extracorporeal membrane oxygenation in this group will receive heparin infusion, based on weight (if body weight <50 kg: 8 000 units/24 hours; if body weight comprised between 50 and 70 kg: heparin 10 000 units /24 hours; if body weight >70 kg: 12 000 units/ 24 hours) in absence of any indication for full systemic anticoagulation, and in absence of bleeding. If the Activated Partial Thromboplastin Time (APTT) is higher than 45, the heparin will be withhold unt
Critically ill patients undergoing extracorporeal membrane oxygenation in this group will receive heparin infusion, based on weight (if body weight <50 kg: 8 000 units/24 hours; if body weight comprised between 50 and 70 kg: heparin 10 000 units /24 hours; if body weight >70 kg: 12 000 units/ 24 hours) in absence of any indication for full systemic anticoagulation, and in absence of bleeding. If the Activated Partial Thromboplastin Time (APTT) is higher than 45, the heparin will be withhold until the APTT is equal or less than 45seconds. The APTT is monitored 6 hourly. The intervention will last until the ECMO is removed
Sponsors
Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed