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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedOctober 6, 2017
October 1, 2017
8 months
May 20, 2016
October 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative bleeding
According to UDPB severe or massive bleeding,
12 hours after chest closure
Secondary Outcomes (2)
Postoperative transfusions
12 hours after chest closure
Bleeding according to other validated definitions
12 hours after chest closure
Study Arms (2)
HeProCalc
ACTIVE COMPARATORThis arm receives heparin and protamine doses according to the novel HeProCalc calculation model.
Traditional calculations
NO INTERVENTIONThis arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT)
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing cardiac surgery with the use of cardiopulmonary bypass
- Indication and planned use of heparin and protamine
You may not qualify if:
- Inability to leave informed consent or understanding the outline of the study
- Known coagulation disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Karolinska Institutetcollaborator
Study Sites (1)
Karolinska University Hospital
Stockholm, S17176, Sweden
Related 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.
PMID: 26270199BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 20, 2016
First Posted
May 30, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
February 1, 2018
Last Updated
October 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
On a group level in the planned publication. Upon request we will will share de-identified original data.