Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

February 14, 2022 updated by: Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Namur, Belgium, 5004
        • Clinique Saint-Luc of Bouge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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.
Drug: Heparin
300 IU of heparin
Experimental: 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.
Diagnostic test: 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.
Drug: Heparin
300 IU of heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACT performance
Time Frame: 1 minute
Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDKR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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