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

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ClinicalTrials.gov Identifier: NCT02083549
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Majed Refaai, University of Rochester

Tracking Information
First Submitted Date March 5, 2014
First Posted Date March 11, 2014
Last Update Posted Date February 26, 2020
Actual Study Start Date April 2013
Actual Primary Completion Date December 16, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 10, 2014)
Haemostasis clot kinetics [ Time Frame: 24 hours ]
Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 10, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Evaluating URMC's Massive Transfusion Protocol
Official Title Evaluating the Efficacy of the University of Rochester Medical Center's Massive Transfusion Protocol in Trauma Level 1 Patients Utilizing Thromboelastography
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Blood Coagulation Disorders
  • Trauma
  • Acute Coagulopathy
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: Blood collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2020)
2
Original Estimated Enrollment
 (submitted: March 10, 2014)
40
Actual Study Completion Date December 16, 2014
Actual Primary Completion Date December 16, 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02083549
Other Study ID Numbers UR- MTP-TEG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Majed Refaai, University of Rochester
Study Sponsor University of Rochester
Collaborators Not Provided
Investigators
Principal Investigator: Majed Refaai, MD University of Rochester
PRS Account University of Rochester
Verification Date February 2020