Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pelvic Ring Fracture, Pelvic Bleeding, Polytrauma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no EES<br>Patients with a Type-C pelvic ring fracture who underwent no external emergency stabilization (EES) for the posterior pelvic ring | |
| Pelvic binder<br>Patients with a Type-C pelvic ring fracture who received a pelvic binder for emergency stabilization of the posterior pelvic ring | |
| Pelvic C-clamp<br>Patients with a Type-C pelvic ring fracture who received a pelvic C-clamp for emergency stabilization of the posterior pelvic ring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for transfusion | Number of transfused units of packed red blood cells | 24 hours | 
| Time until emergency stabilization | The time until emergency stabilization device is placed in minutes | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | The rate of deaths due to fatal bleeding | 6 months | 
| Length of hospital stay | Duration of the inpatient treatment in days | 6 months | 
| Complication rate | The rate of overall complications | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic binder, Pelvic C-clamp, Pelvic ring fracture, Fatal pelvic bleeging, Emergency stabilization