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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01462968
• Other study ID #: N-20110037
• Status: Withdrawn
• Phase: N/A
• First received: October 17, 2011
• Last updated: June 25, 2015
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2011
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency (2008-58-0028)Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Device:
• Activated clotting time versus blood-heparin concentration
Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration

Locations

Country	Name	City	State
Denmark	Aalborg Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Medtronic

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta Thrombingeneration	Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	No
Secondary	peroperative heparine/protaminesulphate ratio		The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours	No
Secondary	Platelet function	Platelet aggregation measured by Multiplate platelet function analyzer	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	No
Secondary	Thromboelastometry	We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness	Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	No
Secondary	Standard coagulationtests		Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.	No