Clinical trial NCT04410952: Pelvic Binder vs. Pelvic C-clamp for Bleeding Control
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Ring Fracture
Pelvic Bleeding
Polytrauma
Keywords: Pelvic binder
Pelvic C-clamp
Pelvic ring fracture
Fatal pelvic bleeging
Emergency stabilization
Lead sponsor: BG Trauma Center Tuebingen
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Need for transfusion
timeFrame: 24 hours
measure: Time until emergency stabilization
timeFrame: 6 hours
Secondary outcomes:
measure: Mortality rate
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 6 months
measure: Complication rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: BG Trauma Center
Study officials:
affiliation: BG Trauma Center Tübingen
name: Markus A. Küper, MD
role: PRINCIPAL_INVESTIGATOR
References: