Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

NCT03752437 — Phase 4, Completed, 150 participants, Astes

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03752437
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, other
Enrollment	150 (Actual)
Sponsor	Astes (Other)
Conditions	Extracorporeal Circulation; Complications
Interventions	ACT (Activated Clotting Time), Heparin (Diagnostic test, drug)
Dates	start 2019-10-01, primary completion 2021-09-30, completion 2021-09-30, first posted 2018-11-26, last updated 2022-02-15
Locations	1 site in Belgium

-Summary

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

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Real Weight	Experimental	Diagnostic Test: ACT (Activated Clotting Time); Drug: 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.
Ideal Weight	Experimental	Diagnostic Test: ACT (Activated Clotting Time); Drug: 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.

ACT (Activated Clotting Time) (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 (Drug): 300 IU of heparin

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Clinique Saint-Luc of Bouge	Namur	Belgium

+Investigators

Eric Deflandre, MD, PhD, Principal investigator, Astes

My Notes

Public

To Read Reading Read