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

NCT01462968 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-06-26

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery

Interventions

DEVICE

Activated clotting time versus blood-heparin concentration

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Susanne de Neergaard, Perfusionist · Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01462968 on ClinicalTrials.gov