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

NCT02675647 | Completed Phase 4

• 2 other identifiers: 61242015-003138-28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  at 3 minutes after the first heparin injection

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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

Control group; Intervention group

Cardiopulmonary bypass PROCEDURE

Control group; Intervention group

Protamin administration DRUG

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients (BMI ≥ 30 kg/m²)
• Planned cardiac surgery under cardiopulmonary bypass
• Coronary-artery bypass graft, or valve surgery)
• Age ≥ 18 yo

You may not qualify if:

• Allergy to heparin
• Emergency surgical intervention
• Redo surgery
• Heart transplantation
• Surgery for circulatory assistance
• Pre-operative heparin use

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 29521662 RESULT

MeSH Terms

Interventions

Heparin; Cardiopulmonary Bypass

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: February 5, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 16, 2026

Record last verified: 2025-12

Locations

FR (1)