A comparison between different strategies to handle anticoagulation during cardiac surgery

• Register: ISRCTN
• Last refreshed on: 20 February 2023
• Main ID: ISRCTN14201041
• Date of registration: 14/01/2015
• Prospective Registration: No
• Primary sponsor: Sahlgrenska University Hospital
• Public title: A comparison between different strategies to handle anticoagulation during cardiac surgery
• Scientific title: Heparin titration vs standard dosing - effects on postoperative hemostasis: a prospective randomized study
• Date of first enrolment: 25/10/2011
• Target sample size: 60
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14201041
• Study type: Interventional
• Study design: Prospective randomized open controlled single center study with blinded evaluation (Treatment)
• Phase: Not Specified

Countries of recruitment

Sweden

Contacts

• Name: Anders Jeppsson

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients undergoing elective coronary artery bypass grafting surgery or single valve repair/replacement on cardiopulmonary bypass
2. >18 years old

Exclusion criteria:
1. Acute operation
2. Known bleeding disorder, liver or kidney disease,
3. Previous stroke
4. Treatment with a P2Y12 receptor antagonist <5 days before surgery


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Study anticoagulation strategies during cardiopulmonary bypass.
Circulatory System

Intervention(s)

1. Intervention group: HEPCON Haemostasis Management System Plus device (Medtronic Inc, Minneapolis, Minnesota) was used, according to manufacturer’s recommendations. After estimating the patients’ blood volume and individualized heparin sensitivity, the initial bolus heparin dose, heparin dose response and ACT were determined using a six channel cartridge (two channels with heparin concentration 2.5 U/ml, two with heparin concentration 1.5 U/ml and two without added heparin). Since the CPB circuit has already been primed with 10 000 U heparin, only bolus doses of heparin were estimated every 20 to 30 min throughout the surgery, in order to maintain target ACT above 480 s. At the end of the CPB, the protamine dose required for heparin neutralization was also established using the device.
2. Control group: The patients received unfractionated heparin (350 units/kg body weight) in order to achieve target activated clotting time (ACT) of more than 480 seconds. Heparin monitoring intraoperatively was performed by standard ACT (HEMOCHRON Jr. ACT+ [ITC, Edison,NJ]). After CPB, the heparin was reversed by administration of protamine sulphate (1mg protamine/100 units of the initial heparin dose).

Primary Outcome(s)

Endogenous thrombin potential in plasma 2 hours after surgery as assessed by calibrated automated thrombogram.

Secondary Outcome(s)

1. Total heparin and protamine doses during the operation
2. Whole blood clot formation as measured with thromboelastometry 10 min, 2h and 4h after the operation
3. Hemostatic analyses (aPTT, PT, anti-thrombin, fibrinogen, platelet count) 10 min, 2h and 4h after the operation
4. Postoperative bleeding volume the first 12 h, Red blood cell transfusion during hospital stay

Secondary ID(s)

308-11

Source(s) of Monetary Support

Västra Götaland Region (Sweden), Hjärt-Lungfonden

Ethics review

Status:
Approval date:
Contact:

Regional Research Ethics Committee in Gothenburg, 18/04/2011, ref: 308-11

Results

• Results available: Yes
• Date Completed: 01/04/2013