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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02785575
Enrollment
200
Registered
2016-05-30
Start date
2016-04-30
Completion date
2018-02-28
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Cardiac Surgery, Heparin, Protamine Sulfate, Transfusion

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.

Interventions

OTHERHeProCalc algorithm

Heparin and protamine dosage calculated by the algorithm HeProCalc

Sponsors

Karolinska Institutet
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative bleeding12 hours after chest closureAccording to UDPB severe or massive bleeding,

Secondary

MeasureTime frameDescription
Postoperative transfusions12 hours after chest closure12 hours after chest closure
Bleeding according to other validated definitions12 hours after chest closurePLATO major or life-threatening bleeding, BART massive bleeding, BARC CABG-related bleeding

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026