Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04216225
Status:
UNKNOWN
Last Update Posted:
2021-12-10
First Post:
2019-12-30
Brief Title:
Pre-hospital Tourniquet in Extremity Injury
Sponsor:
Methodist Health System
Organization:
Methodist Health System
Study Overview
Official Title:
Prospective Observational Multi-center Analysis of Pre-hospital Tourniquet in Extremity Injury
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
ENROLLING_BY_INVITATION
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:
21 Objective
Primary Objective To compare outcomes of patients with extremity injuries presenting with or without pre-hospital tourniquet placement
22 Study Outcome Measures
Primary Outcome Incidence of arrival in shock SBP 90
Secondary Outcomes Demographics comorbidities mechanism of injury cause of injury diagnosis codes procedure codes Injury Severity Scale Abbreviated Injury Scale operative management vs non-operative management radiologic findings pathologic findings tourniquet effectiveness as determined both subjectively by trauma surgeon and objectively by presence vs absence of pulse below level of tourniquet application total number of units of blood products transfused within first 24 hrs total number of units of blood products for index admission type of blood products or other fluid given hospital length of stay ICU length of stay ventilator days infectious complications other complications discharge disposition 24 hr mortality overall mortality
Primary Objective To compare outcomes of patients with extremity injuries presenting with or without pre-hospital tourniquet placement
22 Study Outcome Measures
Primary Outcome Incidence of arrival in shock SBP 90
Secondary Outcomes Demographics comorbidities mechanism of injury cause of injury diagnosis codes procedure codes Injury Severity Scale Abbreviated Injury Scale operative management vs non-operative management radiologic findings pathologic findings tourniquet effectiveness as determined both subjectively by trauma surgeon and objectively by presence vs absence of pulse below level of tourniquet application total number of units of blood products transfused within first 24 hrs total number of units of blood products for index admission type of blood products or other fluid given hospital length of stay ICU length of stay ventilator days infectious complications other complications discharge disposition 24 hr mortality overall mortality
Detailed Description:
This is a prospective observational study All patients who present to the participating EDs who meet inclusionexclusion criteria will be identified by the treating trauma surgeons Data collected will include basic patient demographics data regarding the patients injuries data regarding tourniquet use and data regarding outcomes Please see the attached data collection tool for specifics Appendix 121 Data will be collected prospectively in an observational manner using the data collection tool Data collected on individual collection sheets will be de-identified We plan to complete the data collection and analysis by 01012021
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