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
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 |
Verified date | June 2020 |
Source | BG Trauma Center Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | BG Trauma Center | Tübingen |
Lead Sponsor | Collaborator |
---|---|
BG Trauma Center Tuebingen |
Germany,
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 |
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