Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Phase 4

Completed

• Conditions: Extracorporeal Circulation; Complications
• Interventions: Diagnostic Test: ACT (Activated Clotting Time); Drug: Heparin

• Registration Number: NCT03752437
• Lead Sponsor: Astes

Brief Summary

In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.

Detailed Description

In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-26
• Study Start: 2019-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All patients admitted for cardiac open chest surgery

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Exclusion Criteria

• Patient's refusal
• Antithrombin III factor < 75%
• Patient under treatment by heparin IV

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real Weight	ACT (Activated Clotting Time)	Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.
Ideal Weight	ACT (Activated Clotting Time)	Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.
Ideal Weight	Heparin	Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.
Real Weight	Heparin	Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.

Primary Outcome Measures

Name	Time	Method
ACT performance	1 minute	Measure of ACT to be \> 400 seconds to allow extracorporeal circulation, but also \< 700 seconds to avoid excessive bleeding.

Trial Locations

Locations (1)

Clinique Saint-Luc of Bouge; 🇧🇪 Namur, Belgium