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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cardiac Surgery trials