Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery

Aalborg University Hospital

Status: Withdrawn

Conditions: Cardiac Surgery

Treatments: Device: Activated clotting time versus blood-heparin concentration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01462968

N-20110037

Details and patient eligibility

About

The purpose of this study is to find the heparinization method, which

1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.

The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective on-pump coronary artery bypass grafting (CABG) single procedure
• Elective aortavalve replacement (AVR) (single procedure)

Exclusion criteria

• Emergency procedures
• Children and youngsters less than 18 years
• Pregnancy
• Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)
• Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)
• Known coagulopathy
• Endocarditis
• Preoperative anaemia
• Dialysis patients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Activated clotting time (ACT) group

Active Comparator group

Description:

heparinization measured as activated clotting time during surgery

Treatment:

Device: Activated clotting time versus blood-heparin concentration

Hepcon group

Experimental group

Description:

heparinization measured as heparin concentration in the blood during surgery

Treatment:

Device: Activated clotting time versus blood-heparin concentration