Evaluating URMC's Massive Transfusion Protocol

Trauma Clinical Trial

— MTP-TEG  

Official title:

Evaluating the Efficacy of the University of Rochester Medical Center's Massive Transfusion Protocol in Trauma Level 1 Patients Utilizing Thromboelastography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083549
• Other study ID #: UR- MTP-TEG
• Status: Completed
• Start date: April 2013
• Est. completion date: December 16, 2014

Study information

• Verified date: February 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 16, 2014
• Est. primary completion date: December 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coagulopathy
• Blood Coagulation Disorders
• Hemostatic Disorders
• Trauma

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.

Locations

Country	Name	City	State
United States	Strong Hospital at University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standard clinical data	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.	24 hours
Primary	Efficacy of Blood product ratio	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.	24 hours
Secondary	Haemostasis clot kinetics	Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.	24 hours