Heparin Based on Ideal Body Weight for Cardiopulmonary Bypass in Obese Patients

Cardiac Surgery Clinical Trial

— HEPOIRINE  

Official title:

Heparin Management for Cardiopulmonary Bypass in Cardiac Surgery: A Prospective, Comparative and Randomized Study Evaluating a Dosage Based on the Ideal Body Weight in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02675647
• Other study ID #: 6124
• Status: Recruiting
• Phase: Phase 4
• First received: November 26, 2015
• Last updated: February 4, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: University Hospital, Strasbourg, France
• Contact: Emmanuel HAAS, Doctor
• Phone: 3.69.55.12.64
• Email: emmanuel.haas[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients.

Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative bleeding.

To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed.

The main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB surgery with heparin management based of total body weight.

The secondary objectives are to evaluate the relationship between heparin level and ACT in each group of patients and at different time points during CPB, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Obese patients (BMI = 30 kg/m²)

• Planned cardiac surgery under cardiopulmonary bypass

• Coronary-artery bypass graft, or valve surgery)

• Age = 18 yo

Exclusion criteria:

• Allergy to heparin

• Emergency surgical intervention

• Redo surgery

• Heart transplantation

• Surgery for circulatory assistance

• Pre-operative heparin use

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Cardiac Surgery
• Cardiopulmonary Bypass
• Obese Patients (BMI = 30 kg/m²)

Intervention

Drug:
• Heparin, IV route, based on patients body weights (UI/kg)

Procedure:
• Cardiopulmonary bypass

Drug:
• Protamin administration

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma heparin level (anti-Xa activity, in UI/ml)		at 3 minutes after the first heparin injection	No
Secondary	Activated Clotting Time		during the intervention	No
Secondary	Plasma Antithrombin III level		during the intervention at 3 minutes after heparin injection (=T1)	No
Secondary	numbers of labile blood products transfused		during the surgery and the first 24 hours in ICU	No
Secondary	Postoperative bleedings		during the first 24 hours in ICU, based on chest tube outputs	No