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OpenTrials
Completed

NCT Number: NCT02083549

Evaluating URMC's Massive Transfusion Protocol

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.

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Key information

Conditions

Blood Coagulation Disorders Acute Coagulopathy Hematologic Diseases Hemic and Lymphatic Diseases Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Strong Hospital at University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Haemostasis clot kinetics

    Time frame: 24 hours

    Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: MTP-TEG

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2014
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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