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difficult enrollment after the primary investigator left the centre
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An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery.
The investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2) | Procedure | Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not |
| Measure | Description | Time Frame |
|---|---|---|
| renal function |
| Measure | Description | Time Frame |
|---|---|---|
| other organ damage | ||
| prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay | ||
| sepsis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Landoni, MD | Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia | Study Director |
| Giuseppe Crescenzi, MD | Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007431 | Intraoperative Complications |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| exitus |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |