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

Phase 4

• Conditions: Bleeding; Cardiac Surgery; Protamine Sulfate; Transfusion; Heparin
• Interventions: Other: HeProCalc algorithm

• Registration Number: NCT02785575
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-30
• Primary Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeProCalc	HeProCalc algorithm	This arm receives heparin and protamine doses according to the novel HeProCalc calculation model.

Primary Outcome Measures

Name	Time	Method
Postoperative bleeding	12 hours after chest closure	According to UDPB severe or massive bleeding,

Secondary Outcome Measures

Name	Time	Method
Postoperative transfusions	12 hours after chest closure	12 hours after chest closure
Bleeding according to other validated definitions	12 hours after chest closure	PLATO major or life-threatening bleeding, BART massive bleeding, BARC CABG-related bleeding

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden