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| Name | Class |
|---|---|
| University of Manitoba | OTHER |
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The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HES (130/0.4) | Active Comparator | 33 ml/kg i.v. HES (130/0.4) |
|
| Ringer's Lactate | Placebo Comparator | 33 ml/kg i.v. Rigner's Lactate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HES (130/0.4) | Other | 33 ml/kg i.v. during surgery |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB). | first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization | first 24 postoperative hours | |
| Re-exploration for bleeding | first 24 postoperative hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Ringer's Lactate | Other | 33 ml/kg i.v. |
|
| Total intravenous volume administration required in OR and during first 24 hours post-op hours. | first 24 postoperative hours |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| C485123 | HES 130-0.4 |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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