Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

NCT ID: NCT04410952

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2020-05-15

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.

Conditions

Pelvic Ring Fracture; Pelvic Bleeding; Polytrauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

no EES

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

No interventions assigned to this group

Pelvic binder

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BG Trauma Center Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Markus Küper

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus A. Küper, MD

Role: PRINCIPAL_INVESTIGATOR

BG Trauma Center Tübingen

Locations

BG Trauma Center

Tübingen, , Germany

Countries

Germany

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id