Clinical trial NCT02675647: Heparin Based on Ideal Body Weight for Cardiopulmonary Bypass in Obese Patients
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Obese Patients (BMI ≥ 30 kg/m²)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Plasma heparin level (anti-Xa activity, in UI/ml)
timeFrame: at 3 minutes after the first heparin injection
Secondary outcomes:
measure: Activated Clotting Time
timeFrame: during the intervention
measure: Plasma Antithrombin III level
timeFrame: during the intervention at 3 minutes after heparin injection (=T1)
measure: numbers of labile blood products transfused
timeFrame: during the surgery and the first 24 hours in ICU
measure: Postoperative bleedings
timeFrame: during the first 24 hours in ICU, based on chest tube outputs
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
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.