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OpenTrials
Completed

NCT Number: NCT04410952

Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BG Trauma Center

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Need for transfusion

    Time frame: 24 hours

    Number of transfused units of packed red blood cells

  2. Time until emergency stabilization

    Time frame: 6 hours

    The time until emergency stabilization device is placed in minutes

Secondary outcomes

  1. Mortality rate

    Time frame: 6 months

    The rate of deaths due to fatal bleeding

  2. Length of hospital stay

    Time frame: 6 months

    Duration of the inpatient treatment in days

  3. Complication rate

    Time frame: 6 months

    The rate of overall complications

Sponsors and collaborators

Lead sponsor

BG Trauma Center Tuebingen

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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