Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation

Bryan Cotton1,604 enrolled

Overview

The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,604

Conditions

Trauma Injury

Interventions

CryoprecipitateBIOLOGICAL

Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).

Red Blood CellsBIOLOGICAL

RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.

PlasmaBIOLOGICAL

Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is judged to be an adult (according to local practice, e.g. 16 years or older in UK) and has sustained severe traumatic injury. In the event the age is unknown, estimated body weight ≥50 kg. * The patient is deemed by the attending clinician to have on-going active hemorrhage AND REQUIRES Activation of the local major hemorrhage protocol for management of severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood component Exclusion Criteria: * The patient has been transferred from another hospital * The trauma team leader deems the injuries incompatible with life * More than 3 hours have elapsed from the time of injury * Prisoner (as defined as someone admitted from a correctional facility) * Known "Do Not Resuscitate" orders * Enrolled in a concurrent ongoing interventional, randomized clinical trial * Patients who wear "opt out" bracelet for study * Obvious pregnancy * Severely burned

Locations (25)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Mortality From Any Cause

Mortality from any cause

Time frame: 28 days after emergency department (ED) admission

Secondary Outcomes

All Cause Mortality at 6 Hours

Mortality from any cause

Time frame: 6 hours after ED admission

All Cause Mortality at 24 Hours

Mortality from any cause

Time frame: 24 hours after ED admission

All Cause Mortality at 6 Months

Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.

Time frame: 6 months after ED admission

All Cause Mortality at 12 Months

Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.

Time frame: 12 months after ED admission

Death From Bleeding at 6 Hours

Death related to exsanguination

Time frame: 6 hours after ED admission

Death From Bleeding at 24 Hours

Death related to exsanguination

Time frame: 24 hours after ED admission

Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))

Number of units of RBCs

Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.

Whole BloodBIOLOGICAL

Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.

Queen Elizabeth Hospital

Birmingham, United Kingdom

Royal Sussex County Hospital

Brighton, United Kingdom

Southmead Hospital

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

University Hospital of Coventry and Warwickshire

Coventry, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

University Hospital Aintree

Liverpool, United Kingdom

...and 15 more locations

Transfusion Requirements (Number of Units of Plasma)

Number of units of plasma

Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours

Transfusion Requirements (Number of Units of Platelets)

Number of units of platelets

Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours

Transfusion Requirements (Number of Units of Cryoprecipitate)

Number of units of cryoprecipitate

Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours

Destination of Participant at Time of Discharge From Hospital

Destination of participant at time of discharge from hospital

Time frame: at the time of discharge from hospital, about 11-27 days after admission

Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)

The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.

Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)

Quality of Life as Assessed by the Glasgow Outcome Score

The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome: 1. Death - Severe injury or death without recovery of consciousness 2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions 3. Severe disability - Severe injury with permanent need for help with daily living 4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment 5. Low disability - Light damage with minor neurological and psychological deficits

Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)

Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)

The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.

Time frame: 6 months after ED admission

Quality of Life as Assessed by the Glasgow Outcome Score

Time frame: 6 months after ED admission

Hospital Resource Use as Assessed by Number of Ventilator Days

Number of ventilator days during hospitalization

Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)

Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days

Number of ICU days during hospitalization

Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)

Hospital Resource Use as Assessed by Number of Hospital Days

Total number of hospital days

Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)