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出境医 / 临床实验 / A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring (EMS-BIND)

A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring (EMS-BIND)

Study Description
Brief Summary:
The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, REBOA).

Condition or disease Intervention/treatment
Pelvic Fracture Procedure: Application of circumferential pelvic compression (CPC) device

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Blood products [ Time Frame: 24 hours ]
    We will document the volume of any blood products given within the first 24 hours following injury

  2. Pelvic stabilization and resuscitative techniques [ Time Frame: 24 hours ]
    We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours


Secondary Outcome Measures :
  1. Blood loss [ Time Frame: 24 hours ]
    Total blood volume loss will be calculated within the first 24 hours following injury

  2. Ventilator days [ Time Frame: 24 hours ]
    Number of days that patient spends on a ventilator will be documented

  3. ICU days [ Time Frame: 24 hours ]
    Number of days spent in the ICU will be documented

  4. Length of hospital stay [ Time Frame: 24 hours ]
    Number of days spent in the hospital will be documented

  5. GCS (Glascow Coma Score) [ Time Frame: 24 hours ]
    The GCS is a neurological scale to assess for brain injury. The score is composed of three parts: eyes, verbal and motor. Each component has a different scale. Eyes (1-4), verbal (1-5) and motor (1-6). The sum of all three components result in the overall GCS score (3-15). The higher the score, the less likelihood of brain injury


Other Outcome Measures:
  1. Mortality [ Time Frame: 1 month ]
    Any deaths that occur between index hospitalization and 30 days post-injury will be documented


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 6, 2019
Last Update Posted Date September 1, 2020
Actual Study Start Date May 17, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
  • Blood products [ Time Frame: 24 hours ]
    We will document the volume of any blood products given within the first 24 hours following injury
  • Pelvic stabilization and resuscitative techniques [ Time Frame: 24 hours ]
    We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2019)
  • Blood loss [ Time Frame: 24 hours ]
    Total blood volume loss will be calculated within the first 24 hours following injury
  • Ventilator days [ Time Frame: 24 hours ]
    Number of days that patient spends on a ventilator will be documented
  • ICU days [ Time Frame: 24 hours ]
    Number of days spent in the ICU will be documented
  • Length of hospital stay [ Time Frame: 24 hours ]
    Number of days spent in the hospital will be documented
  • GCS (Glascow Coma Score) [ Time Frame: 24 hours ]
    The GCS is a neurological scale to assess for brain injury. The score is composed of three parts: eyes, verbal and motor. Each component has a different scale. Eyes (1-4), verbal (1-5) and motor (1-6). The sum of all three components result in the overall GCS score (3-15). The higher the score, the less likelihood of brain injury
Original Secondary Outcome Measures
 (submitted: June 4, 2019)
  • Blood loss [ Time Frame: 24 hours ]
    Total blood volume loss will be calculated within the first 24 hours following injury
  • Ventilator days [ Time Frame: 24 hours ]
    Number of days that patient spends on a ventilator will be documented
  • ICU days [ Time Frame: 24 hours ]
    Number of days spent in the ICU will be documented
  • Length of hospital stay [ Time Frame: 24 hours ]
    Number of days spent in the hospital will be documented
  • GCS (Glascow Coma Score) [ Time Frame: 24 hours ]
    GCS is assessed throughout the process of being transported to and cared for at a definitive care facility. Changes in scores will be analyzed
Current Other Pre-specified Outcome Measures
 (submitted: June 4, 2019) 		Mortality [ Time Frame: 1 month ]
Any deaths that occur between index hospitalization and 30 days post-injury will be documented
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Official Title A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Brief Summary The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, REBOA).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with severe pelvic ring disruptions
Condition Pelvic Fracture
Intervention Procedure: Application of circumferential pelvic compression (CPC) device
Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 4, 2019) 		600
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient age between 18 and 64 years, inclusive;
  • Severe blunt or blast traumatic injury;
  • Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C);
  • Circumferential pelvic compression (CPC) device used at any time within 24 hours of injury.
  • Patient must speak either English or Spanish

Exclusion Criteria:

  • Arrival to hospital of definitive care more than 6 hours after injury;
  • Ballistic pelvic injury, other than from a blast mechanism;
  • Time of CPC placement not recorded;
  • Time of injury and time of EMS dispatch unknown;
  • Use of medical anti-shock trousers (MAST);
  • Confirmed dead on arrival to hospital
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977168
Other Study ID Numbers W81XWH-16-2-0060-EMS-BIND
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Major Extremity Trauma Research Consortium
Study Sponsor Major Extremity Trauma Research Consortium
Collaborators Not Provided
Investigators Not Provided
PRS Account Major Extremity Trauma Research Consortium
Verification Date August 2020

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