Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04410952
Other study ID # 002
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03730688 - Non-invasive Limb Compartment Pressure Measurement N/A
Not yet recruiting NCT05544773 - Comparing Trauma Severity Scores Injury Severity Score "ISS", Rapid Emergency Medicine Score "REMS" and Kampala Trauma Score "KTS"
Completed NCT04107818 - Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
Completed NCT03780894 - Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. Phase 1/Phase 2
Completed NCT01193686 - Peer Visitation for OEF/OIF Veterans N/A
Active, not recruiting NCT03098459 - Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study
Completed NCT03588767 - Endocrine Response of the Organism to Polytrauma N/A
Suspended NCT00555126 - Forced Air Versus Endovascular Warming in Polytrauma Patients Phase 4
Not yet recruiting NCT04766944 - Incidence and Associated Risk Factors of ARC in the Trauma Critically Ill Older Than 50 Years Old
Recruiting NCT05794256 - Genderspecific Differences in Hormone Levels After Trauma
Suspended NCT03066817 - Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients Phase 1/Phase 2
Recruiting NCT06351826 - Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department N/A
Not yet recruiting NCT05954936 - Trauma Registry in Villavicencio, Colombia
Completed NCT04335838 - Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients.
Completed NCT05221476 - Red Blood Cell Distribution Width and Charlson Comorbidity Indeces in the Frail Polytraumatized Patient.
Completed NCT04723992 - 25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center
Recruiting NCT06305819 - Effectiveness of a Self-management Program After Traumatic Injury N/A
Active, not recruiting NCT06312436 - The AT-REBOA Target Trial
Active, not recruiting NCT03218280 - Oxidative Stress Expression and Metabolic Imbalance in Critically Ill Polytrauma Patients and the Implications of Antioxidant Therapy on Clinical Outcomes N/A
Completed NCT05074095 - Analysis of Urogenital Injuries in Polytraumatized Patients