NCT03977168

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

3.1 years

First QC Date

June 4, 2019

Last Update Submit

August 29, 2022

Conditions

Pelvic Fracture

Outcome Measures

Primary Outcomes (2)

  • Blood products

    We will document the volume of any blood products given within the first 24 hours following injury

    24 hours

  • Pelvic stabilization and resuscitative techniques

    We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours

    24 hours

Secondary Outcomes (5)

  • Blood loss

    24 hours

  • Ventilator days

    24 hours

  • ICU days

    24 hours

  • Length of hospital stay

    24 hours

  • GCS (Glascow Coma Score)

    24 hours

Other Outcomes (1)

  • Mortality

    1 month

Interventions

Application of circumferential pelvic compression (CPC) devicePROCEDURE

Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe pelvic ring disruptions

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Miami Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

San Antonio Military Medical Center (SAMMC)

San Antonio, Texas, 78234, United States

Location

University of Washington/Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

cytidylyl-(3'-5')-cytidine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

May 17, 2019

Primary Completion

June 30, 2022

Study Completion

September 1, 2022

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations

US(11)