Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

NCT ID: NCT03752437

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Extracorporeal Circulation; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Randomisation by computer, different sheet for encoding data.

Study Groups

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Real Weight

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.

Group Type EXPERIMENTAL

ACT (Activated Clotting Time)

Intervention Type DIAGNOSTIC_TEST

Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.

Heparin

Intervention Type DRUG

300 IU of heparin

Ideal Weight

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.

Group Type EXPERIMENTAL

ACT (Activated Clotting Time)

Intervention Type DIAGNOSTIC_TEST

Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.

Heparin

Intervention Type DRUG

300 IU of heparin

Interventions

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ACT (Activated Clotting Time)

Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.

Intervention Type DIAGNOSTIC_TEST

Heparin

300 IU of heparin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients admitted for cardiac open chest surgery

Exclusion Criteria

* Patient's refusal
* Antithrombin III factor \< 75%
* Patient under treatment by heparin IV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astes

OTHER

Sponsor Role lead

Responsible Party

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Eric DEFLANDRE, MD, PhD, FCCP, FAHA

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Deflandre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Astes

Locations

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Clinique Saint-Luc of Bouge

Namur, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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MDKR

Identifier Type: -

Identifier Source: org_study_id

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