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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
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The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allowed drop in hemoglobin to 4,5-5,5 mmol/L | Active Comparator | Transfusion with red blood cells to level between 4.5-5.5 mmol/L |
|
| Allowed drop in hemoglobin to 5,5-6,5 mmol/L | Experimental | Transfusion with red blood cells to level between 5.5-6.5 mmol/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L | Other | Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in subcutaneous oxygen tension from incision. | The primary endpoint is the change in subcutaneous oxygen tension from incision until the time most patients is still undergoing surgery. Subcutaneous oxygen tension is measured every fifteen minutes throughout surgery. The oxygen tension is measured with a polygraphic electrode (Clark's electrode). | Every fifteen minutes throughout surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation of the brain | Every fifteen minutes throughout surgery | |
| The concentration of lactate in plasma | Every half an hour throughout surgery | |
| Variation in the ST-segment of the ECG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamilla Nielsen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Østerbro | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L | Other | Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L |
|
| Every fifteen minutes throughout surgery |
| Muscular saturation of the deltoid muscle | The change in muscular saturation from incision until the time when most patientes are still undergoing surgery. Furthermore the lowest measured and the last measured muscular saturation is also evaluated. | Every fifteen minutes throughout surgery |
| The change in subcutaneous oxygen tension from incision. | The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery. | Every fifteen minutes throughout surgery |