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Completed

NCT Number: NCT02675647

Heparin Based on Ideal Body Weight for Cardiopulmonary Bypass 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

cardiopulmonary bypass

Procedure

Protamin administration

Drug

Primary outcomes

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

    Time frame: at 3 minutes after the first heparin injection

Secondary outcomes

  1. Activated Clotting Time

    Time frame: during the intervention

  2. Plasma Antithrombin III level

    Time frame: during the intervention at 3 minutes after heparin injection (=T1)

  3. numbers of labile blood products transfused

    Time frame: during the surgery and the first 24 hours in ICU

  4. Postoperative bleedings

    Time frame: during the first 24 hours in ICU, based on chest tube outputs

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study 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

Acronym: HEPOIRINE

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 5, 2016
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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