search
Back to results

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

Primary Purpose

Trauma Injury

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cryoprecipitate
Red Blood Cells
Plasma
Platelets
Whole Blood
Sponsored by
Bryan Cotton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma Injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston
  • Queen Elizabeth Hospital
  • Royal Sussex County Hospital
  • Southmead Hospital
  • Addenbrooke's Hospital
  • University Hospital of Wales
  • University Hospital of Coventry and Warwickshire
  • Hull Royal Infirmary
  • Leeds General Infirmary
  • University Hospital Aintree
  • Royal London Hospital
  • King's College Hospital
  • St. George's Hospital
  • St. Mary's Hospital
  • Manchester Royal Infirmary
  • Salford Royal Hospital
  • James Cook University Hospital
  • Royal Victoria Infirmary
  • Queens Medical Centre
  • John Radcliffe Hospital
  • Derriford Hospital
  • Royal Preston Hospital
  • Northern General Hospital
  • University Hospital Southampton
  • University Hospital of North Staffordshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)

Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)

Arm Description

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).

Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.

Outcomes

Primary Outcome Measures

Number of Participants With Mortality From Any Cause
Mortality from any cause

Secondary Outcome Measures

All Cause Mortality at 6 Hours
Mortality from any cause
All Cause Mortality at 24 Hours
Mortality from any cause
All Cause Mortality at 6 Months
Mortality from any cause
All Cause Mortality at 12 Months
Mortality from any cause
Death From Bleeding at 6 Hours
Death related to exsanguination
Death From Bleeding at 24 Hours
Death related to exsanguination
Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))
Number of units of RBCs
Transfusion Requirements (Number of Units of Plasma)
Number of units of plasma
Transfusion Requirements (Number of Units of Platelets)
Number of units of platelets
Transfusion Requirements (Number of Units of Cryoprecipitate)
Number of units of cryoprecipitate
Destination of Participant at Time of Discharge From Hospital
Disposition of subject at time of discharge
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
EQ5D-5L is reported as an index score ranging from 0 to 1, where 0 is the health state equivalent to dead and 1 is the health state equivalent to full health.
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: 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
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
EQ5D-5L is reported as an index score ranging from 0 to 1, where 0 is the health state equivalent to dead and 1 is the health state equivalent to full health.
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: 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
Hospital Resource Use as Assessed by Number of Ventilator Days
Number of ventilator days during hospitalization
Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days
Number of ICU days during hospitalization
Hospital Resource Use as Assessed by Number of Hospital Days
Total number of hospital days

Full Information

First Posted
January 6, 2021
Last Updated
May 10, 2023
Sponsor
Bryan Cotton
Collaborators
Queen Mary University of London, NHS Blood and Transplant
search

1. Study Identification

Unique Protocol Identification Number
NCT04704869
Brief Title
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bryan Cotton
Collaborators
Queen Mary University of London, NHS Blood and Transplant

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1604 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Arm Type
Experimental
Arm Description
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).
Arm Title
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Arm Type
Active Comparator
Arm Description
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Intervention Type
Biological
Intervention Name(s)
Cryoprecipitate
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Red Blood Cells
Other Intervention Name(s)
RBCs
Intervention Description
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Intervention Type
Biological
Intervention Name(s)
Plasma
Intervention Description
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Intervention Type
Biological
Intervention Name(s)
Platelets
Intervention Description
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Intervention Type
Biological
Intervention Name(s)
Whole Blood
Intervention Description
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Primary Outcome Measure Information:
Title
Number of Participants With Mortality From Any Cause
Description
Mortality from any cause
Time Frame
28 days after emergency department (ED) admission
Secondary Outcome Measure Information:
Title
All Cause Mortality at 6 Hours
Description
Mortality from any cause
Time Frame
6 hours after ED admission
Title
All Cause Mortality at 24 Hours
Description
Mortality from any cause
Time Frame
24 hours after ED admission
Title
All Cause Mortality at 6 Months
Description
Mortality from any cause
Time Frame
6 months after ED admission
Title
All Cause Mortality at 12 Months
Description
Mortality from any cause
Time Frame
12 months after ED admission
Title
Death From Bleeding at 6 Hours
Description
Death related to exsanguination
Time Frame
6 hours after ED admission
Title
Death From Bleeding at 24 Hours
Description
Death related to exsanguination
Time Frame
24 hours after ED admission
Title
Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))
Description
Number of units of RBCs
Time Frame
from time of pre-hospital care to 24 hours after ED admission
Title
Transfusion Requirements (Number of Units of Plasma)
Description
Number of units of plasma
Time Frame
from time of pre-hospital care to 24 hours after ED admission
Title
Transfusion Requirements (Number of Units of Platelets)
Description
Number of units of platelets
Time Frame
from time of pre-hospital care to 24 hours after ED admission
Title
Transfusion Requirements (Number of Units of Cryoprecipitate)
Description
Number of units of cryoprecipitate
Time Frame
from time of pre-hospital care to 24 hours after ED admission
Title
Destination of Participant at Time of Discharge From Hospital
Description
Disposition of subject at time of discharge
Time Frame
at the time of discharge from hospital, about 1-8 days after admission
Title
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
Description
EQ5D-5L is reported as an index score ranging from 0 to 1, where 0 is the health state equivalent to dead and 1 is the health state equivalent to full health.
Time Frame
Day of hospital discharge or 28 days after ED admission (whichever comes first)
Title
Quality of Life as Assessed by the Glasgow Outcome Score
Description
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
Time Frame
Day of hospital discharge or 28 days after ED admission (whichever comes first)
Title
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
Description
EQ5D-5L is reported as an index score ranging from 0 to 1, where 0 is the health state equivalent to dead and 1 is the health state equivalent to full health.
Time Frame
6 months after ED admission
Title
Quality of Life as Assessed by the Glasgow Outcome Score
Description
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
Time Frame
6 months after ED admission
Title
Hospital Resource Use as Assessed by Number of Ventilator Days
Description
Number of ventilator days during hospitalization
Time Frame
Day of hospital discharge or 28 days after ED admission (whichever comes first)
Title
Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days
Description
Number of ICU days during hospitalization
Time Frame
Day of hospital discharge or 28 days after ED admission (whichever comes first)
Title
Hospital Resource Use as Assessed by Number of Hospital Days
Description
Total number of hospital days
Time Frame
Day of hospital discharge or 28 days after ED admission (whichever comes first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan A Cotton, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2N 5BE
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
University Hospital of Coventry and Warwickshire
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
University Hospital Aintree
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queens Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9UD
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs