Cardiac Surgery, Cardiopulmonary Bypass, Obese Patients (BMI ≥ 30 kg/m²)
Conditions
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.
Interventions
DRUGHeparin, IV route, based on patients body weights (UI/kg)
PROCEDURECardiopulmonary bypass
DRUGProtamin administration
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma heparin level (anti-Xa activity, in UI/ml) | at 3 minutes after the first heparin injection |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed