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

Karolinska University Hospital

Status and phase: Unknown; Phase 4

Conditions: Cardiac Surgery; Heparin; Transfusion; Protamine Sulfate; Bleeding

Treatments: Other: HeProCalc algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT02785575

2015/2210

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

HeProCalc

Active Comparator group

Description:

This arm receives heparin and protamine doses according to the novel HeProCalc calculation model.

Treatment:

Other: HeProCalc algorithm

Traditional calculations

No Intervention group

Description:

This arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT)