Evaluating URMC's Massive Transfusion Protocol (MTP-TEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02083549
Recruitment Status : Recruiting
First Posted : March 11, 2014
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
Majed Refaai, 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.

Condition or disease Intervention/treatment
Blood Coagulation Disorders Trauma Acute Coagulopathy Other: Blood collection

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating the Efficacy of the University of Rochester Medical Center's Massive Transfusion Protocol in Trauma Level 1 Patients Utilizing Thromboelastography
Study Start Date : April 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Trauma 1 massively transfused
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.
Other: Blood collection
After transfusion of each shipment of blood products outlined in the current Massive Transfusion Protocol one 2.7mL citrated blood sample will be collected from the subject through the 5th shipment of blood products. A final sample will be collected 24 hours following the discontinuation of the massive transfusion protocol.

Primary Outcome Measures :
  1. Efficacy of Blood product ratio [ Time Frame: 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 :
  1. Haemostasis clot kinetics [ Time Frame: 24 hours ]
    Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.

Other Outcome Measures:
  1. Standard clinical data [ Time Frame: 24 hours ]
    Patient and trauma specific information will be extracted from the patients' record. Including but not limited to age, gender, type of injury and severity score, assessment of blood consumption score, blood type, number and volume of blood transfusions consumed during present trauma, current and past medical history and medications.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population includes level 1 trauma patients brought to the trauma bay for resusitation and are initiated under the Massive Transfusion Protocol.

Inclusion Criteria:

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

Exclusion Criteria:

  • Females who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02083549

Contact: Majed Refaai, MD 585-276-3927
Contact: Annika Swanson 585-275-5657

United States, New York
Strong Hospital at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Annika Swanson    585-275-5657      
Principal Investigator: Majed Refaai, MD         
Sponsors and Collaborators
University of Rochester
Principal Investigator: Majed Refaai, MD University of Rochester

Responsible Party: Majed Refaai, Associate Professor, University of Rochester Identifier: NCT02083549     History of Changes
Other Study ID Numbers: UR- MTP-TEG
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Majed Refaai, University of Rochester:
Massive Transfusion Protocol

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders