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

Not Applicable

Withdrawn

• Conditions: Cardiac Surgery
• Interventions: Device: Activated clotting time versus blood-heparin concentration

• Registration Number: NCT01462968
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-31
• Study Start: 2011-11
• Study First Posted: 2011-11-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepcon group	Activated clotting time versus blood-heparin concentration	heparinization measured as heparin concentration in the blood during surgery
Activated clotting time (ACT) group	Activated clotting time versus blood-heparin concentration	heparinization measured as activated clotting time during surgery

Primary Outcome Measures

Name	Time	Method
Delta Thrombingeneration	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope

Secondary Outcome Measures

Name	Time	Method
peroperative heparine/protaminesulphate ratio	The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours
Platelet function	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	Platelet aggregation measured by Multiplate platelet function analyzer
Thromboelastometry	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness
Standard coagulationtests	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.

Trial Locations

Locations (1)

Aalborg Hospital; 🇩🇰 Aalborg, Denmark