Clinical trial NCT04704869: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Trauma Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
name: NHS Blood and Transplant
First posted: 2021-01-12
Enrollment: 1604
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants With Mortality From Any Cause
timeFrame: 28 days after emergency department (ED) admission
Secondary outcomes:
measure: All Cause Mortality at 6 Hours
timeFrame: 6 hours after ED admission
measure: All Cause Mortality at 24 Hours
timeFrame: 24 hours after ED admission
measure: All Cause Mortality at 6 Months
timeFrame: 6 months after ED admission
measure: All Cause Mortality at 12 Months
timeFrame: 12 months after ED admission
measure: Death From Bleeding at 6 Hours
timeFrame: 6 hours after ED admission
measure: Death From Bleeding at 24 Hours
timeFrame: 24 hours after ED admission
measure: Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))
timeFrame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
measure: Transfusion Requirements (Number of Units of Plasma)
timeFrame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
measure: Transfusion Requirements (Number of Units of Platelets)
timeFrame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
measure: Transfusion Requirements (Number of Units of Cryoprecipitate)
timeFrame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
measure: Destination of Participant at Time of Discharge From Hospital
timeFrame: at the time of discharge from hospital, about 11-27 days after admission
measure: Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
timeFrame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
measure: Quality of Life as Assessed by the Glasgow Outcome Score
timeFrame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
measure: Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
timeFrame: 6 months after ED admission
measure: Quality of Life as Assessed by the Glasgow Outcome Score
timeFrame: 6 months after ED admission
measure: Hospital Resource Use as Assessed by Number of Ventilator Days
timeFrame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
measure: Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days
timeFrame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
measure: Hospital Resource Use as Assessed by Number of Hospital Days
timeFrame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Coventry
country: United Kingdom
facility: University Hospital of Coventry and Warwickshire
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Salford Royal Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Staffordshire
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Bryan A Cotton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891. doi: 10.1001/jama.2023.21019.