Evaluating URMC's Massive Transfusion Protocol

NCT02083549 | Completed

• 1 other identifier: UR- MTP-TEG
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation Disorders; Trauma; Acute Coagulopathy

Keywords

Massive Transfusion Protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Haemostasis clot kinetics

  24 hours

Other Outcomes (1)

• Standard clinical data

  24 hours

Study Arms (1)

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

Interventions

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.

Trauma 1 massively transfused

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Trauma level 1 patient initiated under Massive Transfusion Protocol
• Age greater than or equal to 18 years old

You may not qualify if:

• Females who are pregnant

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Strong Hospital at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Blood Coagulation Disorders; Wounds and Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Majed Refaai, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: April 1, 2013
• Primary Completion: December 16, 2014
• Study Completion: December 16, 2014
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

US (1)