Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

• Sponsor: Astes (Other)
• Overall Status: Completed
• CT.gov ID: NCT03752437
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Extracorporeal Circulation; Complications	Diagnostic Test: ACT (Activated Clotting Time); Drug: Heparin	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Randomisation by computer, different sheet for encoding data.
• Primary Purpose: Other
• Official Title: Comparison of Two Dosages of Heparin Before Extracorporeal Circulation
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ACT performance [1 minute]

   Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Saint-Luc of Bouge	Namur		Belgium	5004

Sponsors and Collaborators

• Astes

Investigators

• Principal Investigator: Eric Deflandre, MD, PhD, Astes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Head of Department, Astes
• ClinicalTrials.gov Identifier: NCT03752437
• Other Study ID Numbers: MDKR
• First Posted: Nov 26, 2018
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heparin

Study Results

No Results Posted as of Feb 15, 2022