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

NCT ID: NCT02785575

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery Bleeding Transfusion Protamine Sulfate Heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HeProCalc

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

Group Type ACTIVE_COMPARATOR

HeProCalc algorithm

Intervention Type OTHER

Heparin and protamine dosage calculated by the algorithm HeProCalc

Traditional calculations

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HeProCalc algorithm

Heparin and protamine dosage calculated by the algorithm HeProCalc

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan van der Linden

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 26270199 (View on PubMed)

Other Identifiers

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2015/2210

Identifier Type: -

Identifier Source: org_study_id