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Completed

NCT Number: NCT04704869

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

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).

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Key information

Conditions

Trauma Injury Accidental Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Elizabeth Hospital, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cryoprecipitate

Biological

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 cells

Biological

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

Other names: RBCs

plasma

Biological

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

Platelets

Biological

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

Whole Blood

Biological

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

Primary outcomes

  1. Number of Participants With Mortality From Any Cause

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

    Mortality from any cause

Secondary outcomes

  1. All Cause Mortality at 6 Hours

    Time frame: 6 hours after ED admission

    Mortality from any cause

  2. All Cause Mortality at 24 Hours

    Time frame: 24 hours after ED admission

    Mortality from any cause

  3. All Cause Mortality at 6 Months

    Time frame: 6 months after ED admission

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

  4. All Cause Mortality at 12 Months

    Time frame: 12 months after ED admission

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

  5. Death From Bleeding at 6 Hours

    Time frame: 6 hours after ED admission

    Death related to exsanguination

  6. Death From Bleeding at 24 Hours

    Time frame: 24 hours after ED admission

    Death related to exsanguination

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

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

    Number of units of RBCs

  8. Transfusion Requirements (Number of Units of Plasma)

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

    Number of units of plasma

  9. Transfusion Requirements (Number of Units of Platelets)

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

    Number of units of platelets

  10. Transfusion Requirements (Number of Units of Cryoprecipitate)

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

    Number of units of cryoprecipitate

  11. Destination of Participant at Time of Discharge From Hospital

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

    Destination of participant at time of discharge from hospital

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

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

    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.

  13. Quality of Life as Assessed by the Glasgow Outcome Score

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

    The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:

    • Death - Severe injury or death without recovery of consciousness
    • Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions
    • Severe disability - Severe injury with permanent need for help with daily living
    • Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment
    • Low disability - Light damage with minor neurological and psychological deficits

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

    Time frame: 6 months after ED admission

    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.

  15. Quality of Life as Assessed by the Glasgow Outcome Score

    Time frame: 6 months after ED admission

    The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:

    • Death - Severe injury or death without recovery of consciousness
    • Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions
    • Severe disability - Severe injury with permanent need for help with daily living
    • Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment
    • Low disability - Light damage with minor neurological and psychological deficits

  16. Hospital Resource Use as Assessed by Number of Ventilator Days

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

    Number of ventilator days during hospitalization

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

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

    Number of ICU days during hospitalization

  18. Hospital Resource Use as Assessed by Number of Hospital Days

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

    Total number of hospital days

Sponsors and collaborators

Lead sponsor

Bryan Cotton

Other

Collaborators

  • NHS Blood and Transplant
  • Queen Mary University of London

Registry information

Official study title

A Multi-center, Randomized, Controlled Trial Evaluating the Effects of Early High-Dose Cryoprecipitate in Adult Patients With Major Trauma Hemorrhage Requiring Major Hemorrhage Protocol (MHP) Activation

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jan 12, 2021
Registry last updated
Jan 14, 2025

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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