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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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The study will compare a novel calculation model (HeProCalc AB) with a standard weight-based and activated clotting time adjusted calculation for the dosing of Heparin and protamine and assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.
During cardiac surgery with cardiopulmonary bypass (CPB), efficient anticoagulation is required in order to avoid microscopic clot formation or, in worst case, massive lift threatening thrombus formation. Heparin is by far the most common drug used to prevent blood from coagulating during CPB. Activated clotting time (ACT) is a point-of-care test of fibrin clotting time that has to be well prolonged to initiate safe CPB.
Following weaning from CPB, heparin is reversed by protamine. Administration of excess doses of protamine may have a deleterious effect on coagulation and contribute to postoperative bleeding with need of blood transfusions. In connection with CPB management, heparin and protamin doses are commonly calculated using body weight and ACT. However, a new Heparin-Protamin-Calculation computer program (HeProCalc) has been developed to provide patient titrated dosing of both heparin and protamin. However, any benefits regarding postoperative bleeding and transfusions has not been thoroughly investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeProCalc | Active Comparator | This arm receives heparin and protamine doses according to the novel HeProCalc calculation model. |
|
| Traditional calculations | No Intervention | This arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeProCalc algorithm | Other | Heparin and protamine dosage calculated by the algorithm HeProCalc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative bleeding | According to UDPB severe or massive bleeding, | 12 hours after chest closure |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative transfusions | 12 hours after chest closure | 12 hours after chest closure |
| Bleeding according to other validated definitions | PLATO major or life-threatening bleeding, BART massive bleeding, BARC CABG-related bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | S17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26270199 | Background | Kjellberg G, Sartipy U, van der Linden J, Nissborg E, Lindvall G. An Adjusted Calculation Model Allows for Reduced Protamine Doses without Increasing Blood Loss in Cardiac Surgery. Thorac Cardiovasc Surg. 2016 Sep;64(6):487-93. doi: 10.1055/s-0035-1558649. Epub 2015 Aug 13. |
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On a group level in the planned publication. Upon request we will will share de-identified original data.
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 hours after chest closure |