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| Name | Class |
|---|---|
| Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | OTHER |
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Standard Heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM) to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
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| Intervention group A | Experimental | Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
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| Intervention group B | Experimental | Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
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| Intervention group C | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Based on patient body weight (UI/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allogeneic transfusions of red blood cells | Percentage of subjects avoiding any allogeneic transfusions of red blood cells | Seven days post-operatively or until discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Allogeneic transfusions of blood products | Percentage of subjects avoiding any allogeneic transfusions | Seven days post-operatively or until discharge, whichever comes first |
| Units of blood product transfusions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugo Tremblay, Bachelor | Contact | 418-656-8711 | 3797 | hugo.tremblay@criucpq.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Voisine, MD | University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Laval | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Randomized control prospective trial
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Participant is blinded to group assignment
Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
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| cardiopulmonary bypass pump flow rate | Procedure | Based on patient body weight (L/min/m2) |
|
Number of units of transfused blood products
| Seven days post-operatively or until discharge, whichever comes first |
| Massive red blood cell transfusions | Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units) | Seven days post-operatively or until discharge, whichever comes first |
| Post-operative complications | Monitoring the safety of strategies by monitoring post-operative complications | Post-operatively from day 0 up to first hospital discharge |
| Bleeding | Per- and post-operative bleeding | Peroperative, 4 and 24 hours post-operative |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |