CompletedNCT03752437Updated Feb 15, 2022

Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

A Phase 4 interventional study of ACT (Activated Clotting Time) and Heparin in Extracorporeal Circulation; Complications, sponsored by Astes. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Astes · Phase 4, Interventional, and Other

Phase: Phase 4
Study type: Interventional
Enrollment: 150
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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.

Conditions studied

Extracorporeal Circulation; Complications

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

All patients admitted for cardiac open chest surgery

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 4
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 150 participants (actual)

Study arms

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) · Drug: 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) · Drug: Heparin

Interventions

Diagnostic testACT (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.
DrugHeparin
300 IU of heparin

What researchers measure

Primary outcomes

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

Study locations

1 site

Clinique Saint-Luc of Bouge
Namur, 5004, Belgium

Registry details

Key details

Study ID: NCT03752437
Lead sponsor: Astes
Responsible party: Eric DEFLANDRE, MD, PhD, FCCP, FAHA (Head of Department, Astes) — Principal investigator
First posted: Nov 26, 2018
Start date: Oct 1, 2019
Primary completion: Sep 30, 2021
Completion: Sep 30, 2021
Last update: Feb 15, 2022

Study contacts

Eric Deflandre, MD, PhD

principal investigator · Astes

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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