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

Trauma Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704869
• Other study ID #: HSC-MS-19-0272
• Secondary ID: ISRCTN14998314
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1604
• Est. completion date: November 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Trauma Injury

Intervention

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).
• Red Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
• Plasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
• Platelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
• Whole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.

Locations

Country	Name	City	State
United Kingdom	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	King's College Hospital	London
United Kingdom	Royal London Hospital	London
United Kingdom	St. George's Hospital	London
United Kingdom	St. Mary's Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Salford Royal Hospital	Manchester
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Queens Medical Centre	Nottingham
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	University Hospital Southampton	Southampton
United Kingdom	University Hospital of North Staffordshire	Stoke-on-Trent
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Bryan Cotton	NHS Blood and Transplant, Queen Mary University of London

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Mortality From Any Cause	Mortality from any cause	28 days after emergency department (ED) admission
Secondary	All Cause Mortality at 6 Hours	Mortality from any cause	6 hours after ED admission
Secondary	All Cause Mortality at 24 Hours	Mortality from any cause	24 hours after ED admission
Secondary	All Cause Mortality at 6 Months	Mortality from any cause	6 months after ED admission
Secondary	All Cause Mortality at 12 Months	Mortality from any cause	12 months after ED admission
Secondary	Death From Bleeding at 6 Hours	Death related to exsanguination	6 hours after ED admission
Secondary	Death From Bleeding at 24 Hours	Death related to exsanguination	24 hours after ED admission
Secondary	Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))	Number of units of RBCs	from time of pre-hospital care to 24 hours after ED admission
Secondary	Transfusion Requirements (Number of Units of Plasma)	Number of units of plasma	from time of pre-hospital care to 24 hours after ED admission
Secondary	Transfusion Requirements (Number of Units of Platelets)	Number of units of platelets	from time of pre-hospital care to 24 hours after ED admission
Secondary	Transfusion Requirements (Number of Units of Cryoprecipitate)	Number of units of cryoprecipitate	from time of pre-hospital care to 24 hours after ED admission
Secondary	Destination of Participant at Time of Discharge From Hospital	Disposition of subject at time of discharge	at the time of discharge from hospital, about 1-8 days after admission
Secondary	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.	Day of hospital discharge or 28 days after ED admission (whichever comes first)
Secondary	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	Day of hospital discharge or 28 days after ED admission (whichever comes first)
Secondary	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.	6 months after ED admission
Secondary	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	6 months after ED admission
Secondary	Hospital Resource Use as Assessed by Number of Ventilator Days	Number of ventilator days during hospitalization	Day of hospital discharge or 28 days after ED admission (whichever comes first)
Secondary	Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days	Number of ICU days during hospitalization	Day of hospital discharge or 28 days after ED admission (whichever comes first)
Secondary	Hospital Resource Use as Assessed by Number of Hospital Days	Total number of hospital days	Day of hospital discharge or 28 days after ED admission (whichever comes first)