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

December 20, 2024 updated by: Bryan Cotton

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1604

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Brighton, United Kingdom, BN2N 5BE
        • Royal Sussex County Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital of Coventry and Warwickshire
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Liverpool, United Kingdom, L9 7AL
        • University Hospital Aintree
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, E1 1BB
        • Royal London Hospital
      • London, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • London, United Kingdom, SW17 0QT
        • St. George's Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom, NG7 2UH
        • Queens Medical Centre
      • Oxford, United Kingdom, OX3 9UD
        • John Radcliffe Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • Southampton, United Kingdom, SO16 6YD
        • University Hospital Southampton
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Biological: Cryoprecipitate
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).
Biological: Red Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Other Names:
  • RBCs
Biological: Plasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Biological: Platelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Biological: Whole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Active Comparator: Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Biological: Red Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Other Names:
  • RBCs
Biological: Plasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Biological: Platelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Biological: Whole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Mortality From Any Cause
Time Frame: 28 days after emergency department (ED) admission
Mortality from any cause
28 days after emergency department (ED) admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All Cause Mortality at 6 Hours
Time Frame: 6 hours after ED admission
Mortality from any cause
6 hours after ED admission
All Cause Mortality at 24 Hours
Time Frame: 24 hours after ED admission
Mortality from any cause
24 hours after ED admission
Death From Bleeding at 6 Hours
Time Frame: 6 hours after ED admission
Death related to exsanguination
6 hours after ED admission
Death From Bleeding at 24 Hours
Time Frame: 24 hours after ED admission
Death related to exsanguination
24 hours after ED admission
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:

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

  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
6 months after ED admission
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
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
Time Frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Number of ICU days during hospitalization
Day of hospital discharge or 28 days after ED admission (whichever comes first)
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
Day of hospital discharge or 28 days after ED admission (whichever comes first)
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.
6 months after ED admission
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.
12 months after ED admission
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
from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
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
from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
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
from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
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
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
Time Frame: at the time of discharge from hospital, about 11-27 days after admission
Destination of participant at time of discharge from hospital
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)
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.
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)
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.
6 months after ED admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bryan Cotton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Queen Mary University of London
NHS Blood and Transplant

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bryan A Cotton, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-19-0272
  • ISRCTN14998314 (Registry Identifier: International Standard Randomised Controlled Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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