Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

Completed

• Conditions: Pelvic Bleeding; Polytrauma; Pelvic Ring Fracture

• Registration Number: NCT04410952
• Lead Sponsor: BG Trauma Center Tuebingen

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.

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 Timeline

• Study Start: 2020-01-07
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-15
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Status Verified: 2020-06
• Study First Posted: 2020-06-01
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Need for transfusion	24 hours	Number of transfused units of packed red blood cells
Time until emergency stabilization	6 hours	The time until emergency stabilization device is placed in minutes

Secondary Outcome Measures

Name	Time	Method
Mortality rate	6 months	The rate of deaths due to fatal bleeding
Complication rate	6 months	The rate of overall complications
Length of hospital stay	6 months	Duration of the inpatient treatment in days

Trial Locations

Locations (1)

BG Trauma Center; 🇩🇪 Tübingen, Germany