Evaluating URMC's Massive Transfusion Protocol

Completed

• Conditions: Blood Coagulation Disorders; Trauma; Acute Coagulopathy
• Interventions: Other: Blood collection

• Registration Number: NCT02083549
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of the study is to evaluate the efficacy of the University of Rochester Medical Center's current Massive Transfusion Protocol.

Upon arrival of trauma level one designated patients the treating team evaluates the patient's injuries. If the patient is initiated under the facilities Massive Transfusion Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study. Study procedures include collection of a blood sample following the transfusion of each shipment, through shipment 5, of blood products outlined in the current Massive Transfusion Protocol.

Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic state through resuscitation. One final blood sample will be collected 24 hours following the discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.

Due to the critical need for medical intervention, consent procedure will be waived at time of enrollment. An authorized representative for the patient will be identified and approached to obtain consent for use of data collected.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Primary Completion: 2014-12-16
• Study Completion: 2014-12-16
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Trauma level 1 patient initiated under Massive Transfusion Protocol
• Age greater than or equal to 18 years old

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Exclusion Criteria

• Females who are pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma 1 massively transfused	Blood collection	Trauma 1 massively transfused patients are identified as a Trauma level one patient by triage through guidelines from the Kessler Regional Trauma Center Trauma Triage Guidelines.

Primary Outcome Measures

Name	Time	Method
Efficacy of Blood product ratio	24 hours	Through thromboelastography testing the coagulopathy of trauma 1 patients receiving massive amounts of blood products in a ratio previously established by the institutions Standard of Procedure will be evaluated to determine the efficacy of the current blood product ratio.

Secondary Outcome Measures

Name	Time	Method
Haemostasis clot kinetics	24 hours	Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.

Trial Locations

Locations (1)

Strong Hospital at University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States