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.|
|ClinicalTrials.gov Identifier: NCT02083549|
Recruitment Status : Recruiting
First Posted : March 11, 2014
Last Update Posted : September 20, 2017
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|
|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|
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.
- 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.
- Haemostasis clot kinetics [ Time Frame: 24 hours ]Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02083549
|Contact: Majed Refaai, MD||585-276-3927||Majed_refaai@urmc.rochester.edu|
|Contact: Annika Swansonemail@example.com|
|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|
|Principal Investigator:||Majed Refaai, MD||University of Rochester|