Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

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

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.

Study Overview

• Status: Completed
• Conditions: Polytrauma; Pelvic Ring Fracture; Pelvic Bleeding

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • BG Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BG Trauma Center Tuebingen
• Investigators: Principal Investigator: Markus A. Küper, MD, BG Trauma Center Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pelvic ring fracture; Pelvic binder; Pelvic C-clamp; Fatal pelvic bleeging; Emergency stabilization
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Fractures, Bone; Multiple Trauma
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No