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

Primary Purpose

Cardiac Surgery, Bleeding, Transfusion

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
HeProCalc algorithm
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

HeProCalc

Traditional calculations

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative bleeding
According to UDPB severe or massive bleeding,

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2016
Last Updated
October 5, 2017
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02785575
Brief Title
Adjusted Calculation of Heparin and Protamin Dosing and Correlation With Postoperative Bleeding and Transfusions
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Bleeding, Transfusion, Protamine Sulfate, Heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HeProCalc
Arm Type
Active Comparator
Arm Description
This arm receives heparin and protamine doses according to the novel HeProCalc calculation model.
Arm Title
Traditional calculations
Arm Type
No Intervention
Arm Description
This arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT)
Intervention Type
Other
Intervention Name(s)
HeProCalc algorithm
Intervention Description
Heparin and protamine dosage calculated by the algorithm HeProCalc
Primary Outcome Measure Information:
Title
Postoperative bleeding
Description
According to UDPB severe or massive bleeding,
Time Frame
12 hours after chest closure
Secondary Outcome Measure Information:
Title
Postoperative transfusions
Description
12 hours after chest closure
Time Frame
12 hours after chest closure
Title
Bleeding according to other validated definitions
Description
PLATO major or life-threatening bleeding, BART massive bleeding, BARC CABG-related bleeding
Time Frame
12 hours after chest closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
S17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On a group level in the planned publication. Upon request we will will share de-identified original data.
Citations:
PubMed Identifier
26270199
Citation
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.
Results Reference
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Adjusted Calculation of Heparin and Protamin Dosing and Correlation With Postoperative Bleeding and Transfusions

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