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

Phase 4

• 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

• Registration Number: NCT02675647
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study Start: 2015-12
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-04
• Last Update Submitted: 2016-02-04
• Study First Posted: 2016-02-05
• Last Update Posted: 2016-02-05
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Cardiopulmonary bypass	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.
Control group	Cardiopulmonary bypass	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.
Control group	Heparin, IV route, based on patients body weights (UI/kg)	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 group	Heparin, IV route, based on patients body weights (UI/kg)	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.
Intervention group	Protamin administration	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.
Control group	Protamin administration	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma Antithrombin III level	during the intervention at 3 minutes after heparin injection (=T1)
Activated Clotting Time	during the intervention
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

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France