Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

Sponsor
BG Trauma Center Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT04410952
Collaborator
(none)
120
1
4.2
28.3

Study Details

Study Description

Brief Summary

Pelvic ring fractures carry a high risk for severe bleeding. Expecially bleeding from the posterior ring might result in a fatal course. Different types of external emergency stabilization (EES) are available for the posterior pelvic ring, namely the non-invasive pelvic binder or the invasive pelvic c-clamp. Which stabilization technique is superior, has not been investigated yet.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Severe bleeding is the major cause of death in unstable pelvic ring fractures. Therefore, a quick and efficient emergency stabilization and bleeding control is inevitable. The pelvic C-clamp and the pelvic binder are efficient tools for temporary bleeding control, especially for the posterior pelvic ring. However, whether these disadvantages make up for a more efficient bleeding control, still needs to be discussed in the guidelines of the emergency management of pelvic ring fractures.

    Patients with a type-C pelvic ring fracture were identified from the German Pelvic Registry (GPR). The patients were divided into three groups of 40 patients: 1. group without emergency stabilization, 2. group treated with pelvic binder and 3. group treated with pelvic C-clamp. The patients were matched according to the following parameters: age, gender, initial RR and HB level. The complication rates and mortality rates were compared between the groups, especially regarding bleeding control, as measured by the amount of transfused blood products. Furthermore, the subjective efficacy of the treatment was assessed. Finally, the time until established bleeding control was compared.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Bleeding Control in Type-C Pelvic Ring Fractures Using the Pelvic C-clamp vs. the Pelvic Binder for Emergency Stabilization - a Matched Pair Analysis From the German Pelvic Registry
    Actual Study Start Date :
    Jan 7, 2020
    Actual Primary Completion Date :
    Apr 30, 2020
    Actual Study Completion Date :
    May 15, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    no EES

    Patients with a Type-C pelvic ring fracture who underwent no external emergency stabilization (EES) for the posterior pelvic ring

    Pelvic binder

    Patients with a Type-C pelvic ring fracture who received a pelvic binder for emergency stabilization of the posterior pelvic ring

    Pelvic C-clamp

    Patients with a Type-C pelvic ring fracture who received a pelvic C-clamp for emergency stabilization of the posterior pelvic ring

    Outcome Measures

    Primary Outcome Measures

    1. Need for transfusion [24 hours]

      Number of transfused units of packed red blood cells

    2. Time until emergency stabilization [6 hours]

      The time until emergency stabilization device is placed in minutes

    Secondary Outcome Measures

    1. Mortality rate [6 months]

      The rate of deaths due to fatal bleeding

    2. Length of hospital stay [6 months]

      Duration of the inpatient treatment in days

    3. Complication rate [6 months]

      The rate of overall complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Written informed consent for data acquisition in the German Pelvic Registry

    • Pelvic ring fracture Type C (AO/OTA)

    • ISS (Abdomen) >8

    Exclusion Criteria:
    • Acetabular fracture

    • Pelvic ring fracture Type A/B (AO/OTA)

    • ISS (Abdomen) <9

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BG Trauma Center Tübingen Germany 72076

    Sponsors and Collaborators

    • BG Trauma Center Tuebingen

    Investigators

    • Principal Investigator: Markus A. Küper, MD, BG Trauma Center Tübingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Markus Küper, PD Dr. med., BG Trauma Center Tuebingen
    ClinicalTrials.gov Identifier:
    NCT04410952
    Other Study ID Numbers:
    • 002
    First Posted:
    Jun 1, 2020
    Last Update Posted:
    Jun 9, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Markus Küper, PD Dr. med., BG Trauma Center Tuebingen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2020