The effect of different ratio's of inhibitors and activators of the coagulation on perioperative hemostasis during cardiac surgery.

Conditions: Patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass
MedDRA version: 17.1Level: LLTClassification code 10006894Term: CABGSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-003359-12-NL

Lead Sponsor: VU University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 98

Inclusion Criteria

•Patients undergoing coronary artery bypass graft (CABG) surgery.
•Age 18-85 years
•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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

•Re-operations
•Emergency operation
•Patients with a history of hematologic disorders or renal replacement therapy.
•Patients with a body mass index (BMI) below 18 kg/m2 or above 35 kg/m2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does a low protamine-to-heparin ratio lead to improved postoperative hemostasis, measured by rotational thromboelastometry (ROTEM), compared to a high protamine-to-heparin ratio?;Secondary Objective: Does a low protamine-to-heparin ratio reduce the postoperative need for blood product transfusion as compared to a high ratio?<br>Are there differences in antithrombin III and thrombin levels following protamine dosing after cardiopulmonary bypass between the low and high ratio groups?;Primary end point(s): Postoperative 24-hour blood loss assessed by wound drainage.;Timepoint(s) of evaluation of this end point: 24 hours following surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Hemostatic monitoring<br>oROTEM: Intem, Heptem, Extem, Fibtem <br>•Clotting Time (CT), <br>•Maximum Clot Firmness (MCF) <br>•Clot Formation Time (CFT)<br>oClassical coagulation tests: <br>•aPTT <br>•PT<br>oActivated Clotting Time (ACT)<br>oAnti-Xa<br>oHeparin concentration<br>oAntithrombin III<br>oThrombin generation<br>•Patient demographics<br>•Surgery time, CPB time, cross-clamp time<br>•Transfusion of blood products;Timepoint(s) of evaluation of this end point: 24 hours following surgery