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

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02785575
• Collaborator: Karolinska Institutet (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 9.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery; Bleeding; Transfusion; Protamine Sulfate; Heparin	Other: HeProCalc algorithm	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HeProCalc This arm receives heparin and protamine doses according to the novel HeProCalc calculation model.	Other: HeProCalc algorithm; Heparin and protamine dosage calculated by the algorithm HeProCalc
No Intervention: Traditional calculations This arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT)

Outcome Measures

Primary Outcome Measures

1. Postoperative bleeding [12 hours after chest closure]

   According to UDPB severe or massive bleeding,

Secondary Outcome Measures

1. Postoperative transfusions [12 hours after chest closure]

   12 hours after chest closure

2. Bleeding according to other validated definitions [12 hours after chest closure]

   PLATO major or life-threatening bleeding, BART massive bleeding, BARC CABG-related bleeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	S17176

Sponsors and Collaborators

• Karolinska University Hospital
• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Jan van der Linden, MD, PhD, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT02785575
• Other Study ID Numbers: 2015/2210
• First Posted: May 30, 2016
• Last Update Posted: Oct 6, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Oct 6, 2017