Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

NCT04410952 | Completed

• 1 other identifier: 002
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Ring Fracture; Pelvic Bleeding; Polytrauma

Keywords

Pelvic binder; Pelvic C-clamp; Pelvic ring fracture; Fatal pelvic bleeging; Emergency stabilization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mortality rate

  6 months

• Length of hospital stay

  6 months

• Complication rate

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a Type-C pelvic ring fracture and an abdominal ISS \>8 are identified from the German Pelvic Registry. Cases in which the external emergency stabilization was not specified were left included. The remaining cases were divided into the different treatment groups: 1. Patients who received no external emergency stabilization. 2. Patients who were treated with a pelvic binder. 3. Patients who were treated with a C-clamp. Age, gender, the initial HB level and the initial blood pressure were used to match the cases of the three groups.

You may qualify if:

• Written informed consent for data acquisition in the German Pelvic Registry
• Pelvic ring fracture Type C (AO/OTA)
• ISS (Abdomen) \>8

You may not qualify if:

• Acetabular fracture
• Pelvic ring fracture Type A/B (AO/OTA)
• ISS (Abdomen) \<9

Sponsors & Collaborators

• BG Trauma Center Tuebingen: lead

Study Sites (1)

BG Trauma Center

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Markus A. Küper, MD

  BG Trauma Center Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 1, 2020
• Study Start: January 7, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 15, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

DE (1)