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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN14998314 | Registry Identifier | International Standard Randomised Controlled Trial Number |
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| Name | Class |
|---|---|
| Queen Mary University of London | OTHER |
| NHS Blood and Transplant | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Experimental | 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). |
|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Active Comparator | Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mortality From Any Cause | Mortality from any cause | 28 days after emergency department (ED) admission |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality at 6 Hours | Mortality from any cause | 6 hours after ED admission |
| All Cause Mortality at 24 Hours | Mortality from any cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan A Cotton, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States | ||
| Queen Elizabeth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37824155 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2019 |
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| Red Blood Cells | Biological | RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control. |
|
|
| Plasma | Biological | Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control. |
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| 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. |
|
| 24 hours after ED admission |
| All Cause Mortality at 6 Months | 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 | Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated. | 12 months after ED admission |
| Death From Bleeding at 6 Hours | Death related to exsanguination | 6 hours after ED admission |
| Death From Bleeding at 24 Hours | Death related to exsanguination | 24 hours after ED admission |
| 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, an average of 30 hours |
| Transfusion Requirements (Number of Units of Plasma) | 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) | 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) | 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 | 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) | 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 the Glasgow Outcome Score | The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:
| 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) | 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 |
| 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:
| 6 months after ED admission |
| 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) |
| 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) |
| 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) |
| Birmingham |
| B15 2TH |
| United Kingdom |
| Royal Sussex County Hospital | Brighton | BN2N 5BE | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| University Hospital of Coventry and Warwickshire | Coventry | CV2 2DX | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| University Hospital Aintree | Liverpool | L9 7AL | United Kingdom |
| Royal London Hospital | London | E1 1BB | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| St. George's Hospital | London | SW17 0QT | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Salford Royal Hospital | Manchester | M6 8HD | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Queens Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9UD | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| University Hospital Southampton | Southampton | SO16 6YD | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | ST4 6QG | United Kingdom |
| FG001 | 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). 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. |
| Completed 28-day Follow up |
|
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity data were only collected from 48 US participants. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race data were only collected from 48 US participants. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Time from injury to ED arrival | Median | Inter-Quartile Range | minutes |
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| Number of Participants who arrived at the Emergency Department with a blunt injury | Number of participants who arrived in the Emergency Department with a blunt injury data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. | Count of Participants | Participants |
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| Number of Participants who arrived to the Emergency Department in cardiac arrest | Number of participants who arrived to the Emergency Department in cardiac arrest were not be collected for 70 in the Massive Transfusion Protocol arm and for 82 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Mortality From Any Cause | Mortality from any cause | Vital status was not available from any source for 34 in the Massive Transfusion Protocol arm and 39 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. Data presented are from an intention to treat analysis. | Posted | Count of Participants | Participants | 28 days after emergency department (ED) admission |
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| Secondary | All Cause Mortality at 6 Hours | Mortality from any cause | Data were not collected for 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Count of Participants | Participants | 6 hours after ED admission |
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| Secondary | All Cause Mortality at 24 Hours | Mortality from any cause | Data were not collected for 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm | Posted | Count of Participants | Participants | 24 hours after ED admission |
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| Secondary | All Cause Mortality at 6 Months | Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months after ED admission |
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| Secondary | All Cause Mortality at 12 Months | Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months after ED admission |
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| Secondary | Death From Bleeding at 6 Hours | Death related to exsanguination | Data were not collected from 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Count of Participants | Participants | 6 hours after ED admission |
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| Secondary | Death From Bleeding at 24 Hours | Death related to exsanguination | Data were not collected from 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Count of Participants | Participants | 24 hours after ED admission |
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| Secondary | Transfusion Requirements (Number of Units of Red Blood Cells (RBCs)) | Number of units of RBCs | Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | Units | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours |
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| Secondary | Transfusion Requirements (Number of Units of Plasma) | Number of units of plasma | Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | units | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours |
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| Secondary | Transfusion Requirements (Number of Units of Platelets) | Number of units of platelets | Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | Units | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours |
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| Secondary | Transfusion Requirements (Number of Units of Cryoprecipitate) | Number of units of cryoprecipitate | Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | Units | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours |
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| Secondary | Destination of Participant at Time of Discharge From Hospital | Destination of participant at time of discharge from hospital | Data were not collected from 431 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 424 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Count of Participants | Participants | at the time of discharge from hospital, about 11-27 days after admission |
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| Secondary | Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) | 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. | Data were not collected from 458 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 475 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | score on a scale | Day of hospital discharge or 28 days after ED admission (whichever comes first) |
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| 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:
| Data were not collected from 93 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 94 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Count of Participants | Participants | Day of hospital discharge or 28 days after ED admission (whichever comes first) |
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| Secondary | Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) | 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. | Data were not collected from 350 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 331 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after ED admission |
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| 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:
| Data for this outcome measure were not collected because the survey was not included on the 6-month follow-up. As a result, no participants received the survey, and therefore, no participants were analyzed in either study arm. | Posted | 6 months after ED admission |
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| Secondary | Hospital Resource Use as Assessed by Number of Ventilator Days | Number of ventilator days during hospitalization | Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | days | Day of hospital discharge or 28 days after ED admission (whichever comes first) |
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| Secondary | Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days | Number of ICU days during hospitalization | Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | days | Day of hospital discharge or 28 days after ED admission (whichever comes first) |
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| Secondary | Hospital Resource Use as Assessed by Number of Hospital Days | Total number of hospital days | Data were not collected from 33 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Posted | Median | Inter-Quartile Range | days | Day of hospital discharge or 28 days after ED admission (whichever comes first) |
|
Day of hospital discharge or 28 days after ED admission (whichever comes first)
28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 201 | 771 | 83 | 805 | 0 | 805 |
| EG001 | 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). 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. | 192 | 760 | 84 | 799 | 0 | 799 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous thromboembolism | Vascular disorders | Systematic Assessment |
| ||
| Arterial thrombotic event | Vascular disorders | Systematic Assessment |
| ||
| Serious transfusion related adverse event | General disorders | Systematic Assessment |
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Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan A Cotton, MD | The University of Texas Health Science Center at Houston | 713-500-7313 | Bryan.A.Cotton@uth.tmc.edu |
| Nov 30, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| C026912 | cryoprecipitate coagulum |
| D004906 | Erythrocyte Count |
| D010976 | Platelet Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D010979 | Platelet Function Tests |
Not provided
Not provided
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| United Kingdom |
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Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. 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. |
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Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. 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. |
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Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. 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. |
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Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. 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. |
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| 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. 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. |
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| 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. 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. |
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| 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. 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. |
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| 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. 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. |
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| 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. 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. |
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| OG001 | 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. 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. |
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| OG001 | 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. 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. |
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| OG001 | 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. 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. |
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| OG001 | 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. 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. |
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| 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. 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. |
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| 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. 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. |
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| 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. 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. |
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