Protamine in Cardiac Surgery and Haemostasis (PROTT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01608971|
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : November 20, 2015
Last Update Posted : March 27, 2017
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|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 Cardiac Surgery|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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.
- INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer [ Time Frame: Tests will be measured 15 minutes after Protamine infusion ]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 [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.
- Rotem MCF Fibtem and MCF Intem [ Time Frame: 15 Minutes after protamine infusion ]The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.
- Transfusion of Blood Products and Coagulation Factors [ Time Frame: From protamine administration until 12 h after surgery ]The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .
- 12 h Postoperative Blood Loss [ Time Frame: 15 min after protamine administration until 12 hours postoperatively ]The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|