Ignite Creation Date:
2024-05-06 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03444077
Status:
UNKNOWN
Last Update Posted:
2018-05-02
First Post:
2018-02-18
Brief Title:
Impact of a Prehospital Identification of Trauma Patients in Need for Damage Control Resuscitation
Sponsor:
University of Liege
Organization:
University of Liege
Study Overview
Official Title:
Impact of a Prehospital Discrimination Between Trauma Patients With or Without Early Acute Coagulopathy of Trauma and the Need for Damage Control Resuscitation a Multicenter Randomized Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Early identification of trauma patients in need for Damage Control Resuscitation DCR has potential to be beneficial for general emergency units that are not expected to be ready for this rare situation 24 hours per day 7 days per week It could also be useful for high performing trauma centers to identify such patients earlier and be able to provide earlier adequate treatment
By contrast initiation of DCR in patients who do not require this aggressive therapy may negatively affect their survival An early identification of patients who do not require DCR would probably be beneficial impact on cost-effectiveness and on patients survival
The evidence of the Trauma Induced Coagulopathy Clinical Score TICCS accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated There has never been any evaluation of the impact of a prehospital discrimination of trauma patients with or without the need for DCR
The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for DCR Secondary objectives include evaluation of the feasibility of such discrimination and its impact on cost-effectiveness We hypothesize that the information will lead to improved quality of care with reduced mortality and morbidity
By contrast initiation of DCR in patients who do not require this aggressive therapy may negatively affect their survival An early identification of patients who do not require DCR would probably be beneficial impact on cost-effectiveness and on patients survival
The evidence of the Trauma Induced Coagulopathy Clinical Score TICCS accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated There has never been any evaluation of the impact of a prehospital discrimination of trauma patients with or without the need for DCR
The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for DCR Secondary objectives include evaluation of the feasibility of such discrimination and its impact on cost-effectiveness We hypothesize that the information will lead to improved quality of care with reduced mortality and morbidity
Detailed Description:
The trial will be designed as randomized phase II clinical trial with comparison of the experimental protocol prehospital discrimination using the TICCS against the standard of care Patients will be allocated in a 11 ratio in two groups the intervention group will benefit from a prehospital evaluation using the TICCS and from a specific treatment protocol regarding the TICCS value The control group will benefit from the standard local care
The trial will involve several participating prehospital and hospital teams across Belgium
Control and intervention group will only differ in the management of potential bleeding and coagulopathy All patients will benefit from the recommended level of care regarding their situation including airway management Traumatic Brain Injury TBI management control of external bleeding cervical spine and extremities immobilization if needed
Control group The patients allocated in the control group will be managed as recommended in the local guidelines and protocols As the trial involves participating centers with different prehospital and hospital realities and local practices the control group will reflect a wide panel of levels of care and will not be limited to a unique approach
Intervention group The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group Those patients will be classified in two categories regarding their TICCS value Patients with TICCS 10 will be classified as in need for DCR while patients with TICCS 10 will be classified as not in need for DCR
TICCS 10 This subgroup will be considered without a need for DCR and without coagulopathy There will not be any activation of the DCR components no phone contact to the blood bank to the surgical team no prehospital transfusion There will be any prehospital treatmentprevention of the hyperfibrinolysis using Tranexamic acid TXA Crystalloids infusion will be allowed All patients will benefit from the recommended level of care regarding their situation airway TBI including trauma team activation if locally recommended
TICCS 10
This subgroup will be considered with a need for DCR and with coagulopathy They will be treated using the STTTOPPP the bleeding protocol The STTTOPPP the bleeding protocol is the acronym for
Surgical team pre-activation
Trauma team pre-activation
Transfusion team pre-activation
Tranexamic acid administration of 1 gram of TXA if documented hyperfibrinolysis
O negative Red Blood Cells RBC transfusion as soon as possible
Plasma and Platelets transfusion as soon as possible
Permissive hypotension restrictive use of crystalloids no more than 500 milliliters before definitive control of the bleeding is achieved
Prophylaxis initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal first evaluation before the 24th hour after trauma
Data will be collected locally in each participating center and will be anonymously recorded on the trial website by the local Principal Investigator or his research assistant The website has been designed to avoid incomplete data will give feedbacks about the number of patients included to this respective centers every six months The participating centers will only have access to their own center database The trial coordination team will have access to the whole database and will not be able to record or change any data After one year of inclusion and in the end of the 24 months period of inclusion data will be extracted for interim and final analysis
The trial will involve several participating prehospital and hospital teams across Belgium
Control and intervention group will only differ in the management of potential bleeding and coagulopathy All patients will benefit from the recommended level of care regarding their situation including airway management Traumatic Brain Injury TBI management control of external bleeding cervical spine and extremities immobilization if needed
Control group The patients allocated in the control group will be managed as recommended in the local guidelines and protocols As the trial involves participating centers with different prehospital and hospital realities and local practices the control group will reflect a wide panel of levels of care and will not be limited to a unique approach
Intervention group The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group Those patients will be classified in two categories regarding their TICCS value Patients with TICCS 10 will be classified as in need for DCR while patients with TICCS 10 will be classified as not in need for DCR
TICCS 10 This subgroup will be considered without a need for DCR and without coagulopathy There will not be any activation of the DCR components no phone contact to the blood bank to the surgical team no prehospital transfusion There will be any prehospital treatmentprevention of the hyperfibrinolysis using Tranexamic acid TXA Crystalloids infusion will be allowed All patients will benefit from the recommended level of care regarding their situation airway TBI including trauma team activation if locally recommended
TICCS 10
This subgroup will be considered with a need for DCR and with coagulopathy They will be treated using the STTTOPPP the bleeding protocol The STTTOPPP the bleeding protocol is the acronym for
Surgical team pre-activation
Trauma team pre-activation
Transfusion team pre-activation
Tranexamic acid administration of 1 gram of TXA if documented hyperfibrinolysis
O negative Red Blood Cells RBC transfusion as soon as possible
Plasma and Platelets transfusion as soon as possible
Permissive hypotension restrictive use of crystalloids no more than 500 milliliters before definitive control of the bleeding is achieved
Prophylaxis initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal first evaluation before the 24th hour after trauma
Data will be collected locally in each participating center and will be anonymously recorded on the trial website by the local Principal Investigator or his research assistant The website has been designed to avoid incomplete data will give feedbacks about the number of patients included to this respective centers every six months The participating centers will only have access to their own center database The trial coordination team will have access to the whole database and will not be able to record or change any data After one year of inclusion and in the end of the 24 months period of inclusion data will be extracted for interim and final analysis
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