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

NCT01462968 | Withdrawn

• 1 other identifier: N-20110037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find the heparinization method, which

1. 1.affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
2. 2.gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.

Conditions

Cardiac Surgery

Keywords

Heparin treatment during cardiac surgery; Heparin reversal after cardiac surgery; Thrombin generation; Endogenous Thrombin potential

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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.

• Thromboelastometry

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

• Standard coagulationtests

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

Study Arms (2)

Activated clotting time (ACT) group

ACTIVE COMPARATOR

heparinization measured as activated clotting time during surgery

Device: Activated clotting time versus blood-heparin concentration

Hepcon group

EXPERIMENTAL

heparinization measured as heparin concentration in the blood during surgery

Device: Activated clotting time versus blood-heparin concentration

Interventions

Activated clotting time versus blood-heparin concentration DEVICE

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

Also known as: ACT, Hemochron Signature Elite, Hepcon, HMS

Activated clotting time (ACT) group; Hepcon group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective on-pump coronary artery bypass grafting (CABG) single procedure
• Elective aortavalve replacement (AVR) (single procedure)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Medtronic: collaborator

Study Sites (1)

Aalborg Hospital

Aalborg, Aalborg, 9000, Denmark

Location

Study Officials

• Susanne de Neergaard, Perfusionist

  Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: November 1, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 26, 2015

Record last verified: 2011-10

Locations

DK (1)