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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Obese Patients (BMI ≥ 30 kg/m²)
• Intervention / Treatment: Drug: Heparin, IV route, based on patients body weights (UI/kg); Procedure: Cardiopulmonary bypass; Drug: Protamin administration

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emmanuel HAAS, Doctor; Phone Number: +33 3.69.55.12.64; Email: emmanuel.haas@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
    • Contact: Emmanuel HAAS; Phone Number: +33 3.69.55.12.64; Email: emmanuel.haas@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma heparin level (anti-Xa activity, in UI/ml)	at 3 minutes after the first heparin injection

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Publications and helpful links

General Publications

• Vienne M, Haas E, Wipf T, Grunebaum L, Levy F, Sattler L, Hoang Minh T, Severac F, Tacquard C, Collange O, Mertes PM, Steib A. Adjusted calculation model of heparin management during cardiopulmonary bypass in obese patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):613-620. doi: 10.1097/EJA.0000000000000784.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Coagulants; Heparin Antagonists; Heparin; Protamines
• Other Study ID Numbers: 6124