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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Majed Refaai, University of Rochester
ClinicalTrials.gov Identifier:
NCT02083549
First received: March 5, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention
Blood Coagulation Disorders
Trauma
Acute Coagulopathy
Other: Blood collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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


Other Outcome Measures:
  • Standard clinical data [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083549

Contacts
Contact: Majed Refaai, MD 585-276-3927 Majed_refaai@urmc.rochester.edu
Contact: Grace Conley 585-275-5657 Grace_conley@urmc.rochester.edu

Locations
United States, New York
Strong Hospital at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Grace Conley    585-275-5657      
Principal Investigator: Majed Refaai, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Majed Refaai, MD University of Rochester
  More Information

No publications provided

Responsible Party: Majed Refaai, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02083549     History of Changes
Other Study ID Numbers: UR- MTP-TEG
Study First Received: March 5, 2014
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Massive Transfusion Protocol

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

ClinicalTrials.gov processed this record on July 24, 2014