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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02675647

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Cardiopulmonary Bypass Obese Patients (BMI ≥ 30 kg/m²)	Drug: Heparin, IV route, based on patients body weights (UI/kg) Procedure: Cardiopulmonary bypass Drug: Protamin administration	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients. The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB.	Drug: Heparin, IV route, based on patients body weights (UI/kg) Procedure: Cardiopulmonary bypass Drug: Protamin administration
Active Comparator: Control group Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients. The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB.	Drug: Heparin, IV route, based on patients body weights (UI/kg) Procedure: Cardiopulmonary bypass Drug: Protamin administration

Arm

Intervention/Treatment

Experimental: Intervention group

Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients. The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB.

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

Procedure: Cardiopulmonary bypass

Drug: Protamin administration

Active Comparator: Control group

Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients. The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB.

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

Procedure: Cardiopulmonary bypass

Drug: Protamin administration

Outcome Measures

Primary Outcome Measures

Plasma heparin level (anti-Xa activity, in UI/ml) [at 3 minutes after the first heparin injection]

Secondary Outcome Measures

Activated Clotting Time [during the intervention]
Plasma Antithrombin III level [during the intervention at 3 minutes after heparin injection (=T1)]
numbers of labile blood products transfused [during the surgery and the first 24 hours in ICU]
Postoperative bleedings [during the first 24 hours in ICU, based on chest tube outputs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT02675647

Other Study ID Numbers:

6124

First Posted:

Feb 5, 2016

Last Update Posted:

Feb 5, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Body Weight

Heparin

Protamines

Study Results

No Results Posted as of Feb 5, 2016