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
Verified date | October 2017 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Karolinska Institutet |
Sweden,
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
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 |
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