Pelvic Binder vs. Pelvic C-clamp for Bleeding Control

Polytrauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410952
• Other study ID #: 002
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: June 2020
• Source: BG Trauma Center Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 15, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hemorrhage
• Multiple Trauma
• Pelvic Bleeding
• Pelvic Ring Fracture
• Polytrauma

Locations

Country	Name	City	State
Germany	BG Trauma Center	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
BG Trauma Center Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for transfusion	Number of transfused units of packed red blood cells	24 hours
Primary	Time until emergency stabilization	The time until emergency stabilization device is placed in minutes	6 hours
Secondary	Mortality rate	The rate of deaths due to fatal bleeding	6 months
Secondary	Length of hospital stay	Duration of the inpatient treatment in days	6 months
Secondary	Complication rate	The rate of overall complications	6 months