Protamine in Cardiac Surgery and Haemostasis (PROTT)
Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a protamine regimen based on the initial heparin dose before CPB might lead to overdose of protamine. In contrast, a protamine regimen based on the actual heparin concentration may avoid this condition. The investigators compare both regimens of protamine dosing in patients undergoing complex surgery with CPB and assess its effect on the amount of protamine given, markers of the coagulation system, utilization of blood products and perioperative blood loss.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effects of Heparin Level Based Versus Weight Based Protamine Dosing on Protamine Demand, Markers of Haemostasis, Blood Product Utilization and Perioperative Blood Loss in Patients Undergoing Extended Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Investigation|
- Intem test of the ROTEM coagulation analyzer [ Time Frame: Intem test will be measured 15 minutes after Protamine infusion ] [ Designated as safety issue: No ]The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT (coagulation time), CFT (clot formation time) and MCF (maximum clot firmness).
- Transfusion of Blood Products and Coagulation Factors [ Time Frame: From protamine administration until 12 h after surgery ] [ Designated as safety issue: No ]The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .
- Perioperative blood loss [ Time Frame: 15 min after protamine administration until 12 hours postoperatively ] [ Designated as safety issue: No ]The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.
|Study Start Date:||January 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Weight based protamine group
In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Heparin level based protamine group
In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608971
|Heart & Diabetes Center NRW|
|Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545|
|Principal Investigator:||Andreas Koster, MD||Heart & Diabetes Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany|