Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-05
Brief Title:
SWiFT Canada Study of Whole Blood in Frontline Trauma
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
SWiFT Canada Study of Whole Blood in Frontline Trauma A Pilot Randomized Controlled Trial Assessing Prehospital Whole Blood Versus Component Therapy in Traumatic Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWiFTCanada
Brief Summary:
Traumatic injuries affect people of all ages races and socioeconomic backgrounds The Global Burden of Disease study showed that globally in 2019 there were more than 44 million deaths due to injury Furthermore unintentional injuries are the leading cause of death for people aged 5-29 years worldwide Uncontrolled bleeding accounts for a significant proportion of these deaths with approximately 20 occurring in the first 24 hours and 40 occurring within the first 30 days
Blood transfusion is a life-saving treatment in the management of bleeding patients until bleeding is controlled in hospital typically delivered through different blood components red blood cells plasma and platelets These components are derived from a whole blood donation and are stored in separate bags units There are challenges in carrying separate blood products such as additional weight in kit bags and transfusing multiple blood products at the scene can delay transport to hospital
In Ontario Ornge Air Ambulance carries red blood cells and plasma to transfuse prehospital However a prehospital transfusion strategy has not been established and practice varies across the Canadian setting and more broadly across the world
This trial aims to investigate if carrying and transfusing two units of whole blood instead of four units two red blood cells and two plasma is feasible and leads to better outcomes for patients
Blood transfusion is a life-saving treatment in the management of bleeding patients until bleeding is controlled in hospital typically delivered through different blood components red blood cells plasma and platelets These components are derived from a whole blood donation and are stored in separate bags units There are challenges in carrying separate blood products such as additional weight in kit bags and transfusing multiple blood products at the scene can delay transport to hospital
In Ontario Ornge Air Ambulance carries red blood cells and plasma to transfuse prehospital However a prehospital transfusion strategy has not been established and practice varies across the Canadian setting and more broadly across the world
This trial aims to investigate if carrying and transfusing two units of whole blood instead of four units two red blood cells and two plasma is feasible and leads to better outcomes for patients
Detailed Description:
Early blood transfusion improves survival in patients with life-threatening bleeding but the optimal transfusion strategy in the prehospital setting has yet to be established Although there is some evidence of benefit with the use of Whole Blood WB there have been no RCTs exploring the clinical effectiveness of prehospital administration of WB versus component therapy for bleeding trauma patients in the Canadian setting The lack of high-quality clinical evidence is recognized in the recent NAC recommendations for the use of WB in Canada
In collaboration with the SWiFT UK team the SWiFT Canada study will follow the SWiFT UK protocol but as adopted for the Canadian context This may allow for future comparisons on effectiveness of the two systems and pilot the ability for two countries with different prehospital systems to be able to follow a similar study protocol for future international RCTs
Lastly we have confirmed the support from CBS for the manufacturing and distribution of WB for the duration of the SWiFT Canada trial Therefore it is essential for patients healthcare professionals and blood services that the clinical effectiveness of prehospital WB transfusion is evaluated in a trial before its widespread implementation across CBS in Canada A national program of WB production would necessitate significant changes in the current manufacturing processes for blood services in order to provide appropriate support for hospitals WB production could potentially affect the supply of blood components required to treat other patients as a unit of WB cannot be used to manufacture other components However it could also be argued that early transfusion of WB may reduce the need for further blood component transfusion when patients arrive at hospital due to earlier control of bleeding Following the proposed objectives of this pilot RCT would enable us to evaluate all these uncertainties and assist in the planning of a future larger RCT
In collaboration with the SWiFT UK team the SWiFT Canada study will follow the SWiFT UK protocol but as adopted for the Canadian context This may allow for future comparisons on effectiveness of the two systems and pilot the ability for two countries with different prehospital systems to be able to follow a similar study protocol for future international RCTs
Lastly we have confirmed the support from CBS for the manufacturing and distribution of WB for the duration of the SWiFT Canada trial Therefore it is essential for patients healthcare professionals and blood services that the clinical effectiveness of prehospital WB transfusion is evaluated in a trial before its widespread implementation across CBS in Canada A national program of WB production would necessitate significant changes in the current manufacturing processes for blood services in order to provide appropriate support for hospitals WB production could potentially affect the supply of blood components required to treat other patients as a unit of WB cannot be used to manufacture other components However it could also be argued that early transfusion of WB may reduce the need for further blood component transfusion when patients arrive at hospital due to earlier control of bleeding Following the proposed objectives of this pilot RCT would enable us to evaluate all these uncertainties and assist in the planning of a future larger RCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None