WithdrawnNot Applicable

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

Stopped: The study never started due to problems with Laboratory facilities in collaborating center

Denmark0Started 2011-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Delta Thrombingeneration

Timeframe: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.

Trial details

NCT IDNCT01462968

SponsorAalborg University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

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