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

Primary Purpose

Cardiac Surgery, Cardiopulmonary Bypass, Obese Patients (BMI ≥ 30 kg/m²)

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Heparin, IV route, based on patients body weights (UI/kg)
Cardiopulmonary bypass
Protamin administration
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Plasma heparin level (anti-Xa activity, in UI/ml)

Secondary Outcome Measures

Activated Clotting Time
Plasma Antithrombin III level
numbers of labile blood products transfused
Postoperative bleedings

Full Information

First Posted
November 26, 2015
Last Updated
February 4, 2016
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02675647
Brief Title
Heparin Based on Ideal Body Weight for Cardiopulmonary Bypass in Obese Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Cardiopulmonary Bypass, Obese Patients (BMI ≥ 30 kg/m²)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Heparin, IV route, based on patients body weights (UI/kg)
Intervention Type
Procedure
Intervention Name(s)
Cardiopulmonary bypass
Intervention Type
Drug
Intervention Name(s)
Protamin administration
Primary Outcome Measure Information:
Title
Plasma heparin level (anti-Xa activity, in UI/ml)
Time Frame
at 3 minutes after the first heparin injection
Secondary Outcome Measure Information:
Title
Activated Clotting Time
Time Frame
during the intervention
Title
Plasma Antithrombin III level
Time Frame
during the intervention at 3 minutes after heparin injection (=T1)
Title
numbers of labile blood products transfused
Time Frame
during the surgery and the first 24 hours in ICU
Title
Postoperative bleedings
Time Frame
during the first 24 hours in ICU, based on chest tube outputs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel HAAS, Doctor
Phone
3.69.55.12.64
Ext
+33
Email
emmanuel.haas@chru-strasbourg.fr
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel HAAS
Phone
3.69.55.12.64
Ext
+33
Email
emmanuel.haas@chru-strasbourg.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
29521662
Citation
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.
Results Reference
derived

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

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