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

NCT02675647 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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

PROCEDURE

Cardiopulmonary bypass

DRUG

Protamin administration

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675647 on ClinicalTrials.gov