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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003138-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin, IV route, based on patients body weights (UI/kg) | Drug |
| ||
| Cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma heparin level (anti-Xa activity, in UI/ml) | at 3 minutes after the first heparin injection |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29521662 | Result | 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. |
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| Procedure |
|
| Protamin administration | Drug |
|
| during the surgery and the first 24 hours in ICU |
| Postoperative bleedings | during the first 24 hours in ICU, based on chest tube outputs |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D002315 | Cardiopulmonary Bypass |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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