Adjusted Calculation of Heparin and Protamin Dosing and Correlation With Postoperative Bleeding and Transfusions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of an Adjusted Calculation Model Regarding Heparin and Protamine Dosing on Bleeding and Transfusions After Cardiac Surgery Compared With Standard Dosing: A Randomized Single Blind Trial

Conditions
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Cardiac Surgery, Bleeding, Transfusion, Protamine Sulfate, Heparin

Intervention / Treatment
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* Other: HeProCalc algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing cardiac surgery with the use of cardiopulmonary bypass Indication and planned use of heparin and protamine Exclusion Criteria: Inability to leave informed consent or understanding the outline of the study Known coagulation disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HeProCalc<br>This arm receives heparin and protamine doses according to the novel HeProCalc calculation model. | Other: HeProCalc algorithm<br>* Heparin and protamine dosage calculated by the algorithm HeProCalc<br>|
| No Intervention: Traditional calculations<br>This arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative bleeding | According to UDPB severe or massive bleeding, | 12 hours after chest closure | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 hours after chest closure |