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NCT03752437 Clinical Trial

Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Extracorporeal Circulation; Complications Clinical Trial

Official title:
Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03752437
Other study ID # MDKR
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2019
Est. completion date September 30, 2021

Study information
Verified date February 2022
Source Astes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Extracorporeal Circulation; Complications

Intervention

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

Locations
Country Name City State
Belgium Clinique Saint-Luc of Bouge Namur

Sponsors (1)
Lead Sponsor Collaborator
Astes

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary ACT performance Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding. 1 minute
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