Evaluating URMC's Massive Transfusion Protocol (MTP-TEG)
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.
Blood Coagulation Disorders
Other: Blood collection
|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|
- 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.
- 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.
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02083549
|Contact: Majed Refaai, MD||585-276-3927||Majed_refaai@urmc.rochester.edu|
|Contact: Grace Conley||585-275-5657||Grace_conley@urmc.rochester.edu|
|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|
|Principal Investigator:||Majed Refaai, MD||University of Rochester|