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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02785575
• Other study ID #: 2015/2210
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 20, 2016
• Last updated: October 5, 2017
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Cardiac Surgery
• Hemorrhage
• Heparin
• Protamine Sulfate
• Transfusion

Intervention

Other:
• HeProCalc algorithm
Heparin and protamine dosage calculated by the algorithm HeProCalc

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative bleeding	According to UDPB severe or massive bleeding,	12 hours after chest closure
Secondary	Postoperative transfusions	12 hours after chest closure	12 hours after chest closure
Secondary	Bleeding according to other validated definitions	PLATO major or life-threatening bleeding, BART massive bleeding, BARC CABG-related bleeding	12 hours after chest closure