Pelvic Ring FractureNCT04410952
Pelvic Binder vs. Pelvic C-clamp for Bleeding Control
An observational study of Pelvic Ring Fracture and Pelvic Bleeding, run by BG Trauma Center Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pelvic Ring Fracture, Pelvic Bleeding, Polytrauma
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2020to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Written informed consent for data acquisition in the German Pelvic Registry
- Pelvic ring fracture Type C (AO/OTA)
- ISS (Abdomen) >8
Who cannot join
- Acetabular fracture
- Pelvic ring fracture Type A/B (AO/OTA)
- ISS (Abdomen) <9
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pelvic Ring Fracture, Pelvic Bleeding, Polytrauma
- Keywords
- Pelvic binder, Pelvic C-clamp, Pelvic ring fracture, Fatal pelvic bleeging, Emergency stabilization
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Need for transfusion
Number of transfused units of packed red blood cells
Measured: 24 hours
Time until emergency stabilization
The time until emergency stabilization device is placed in minutes
Measured: 6 hours
Secondary outcomes (3)
Mortality rate
The rate of deaths due to fatal bleeding
Measured: 6 months
Length of hospital stay
Duration of the inpatient treatment in days
Measured: 6 months
Complication rate
The rate of overall complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start7 Jan 2020
- Primary completion30 Apr 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Ring FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- BG Trauma Center Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Küper, BG Trauma Center Tuebingen
- Investigators
- Markus A. Küper, MD, Principal investigator, BG Trauma Center Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410952
- Sponsor's protocol ID
- 002
- Status last verified
- Jun 2020
- First submitted
- 28 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04410952
- Acronym / sponsor ID
- 002
- Conditions
- Pelvic Ring Fracture, Pelvic Bleeding, Polytrauma
- Keywords
- Pelvic binder, Pelvic C-clamp, Pelvic ring fracture, Fatal pelvic bleeging, Emergency stabilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BG Trauma Center TuebingenUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Written informed consent for data acquisition in the German Pelvic Registry
- Pelvic ring fracture Type C (AO/OTA)
- ISS (Abdomen) >8
Key exclusion criteria (3 listed)
- Acetabular fracture
- Pelvic ring fracture Type A/B (AO/OTA)
- ISS (Abdomen) <9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Need for transfusion
Time frame: 24 hours
Number of transfused units of packed red blood cells
Time until emergency stabilization
Time frame: 6 hours
The time until emergency stabilization device is placed in minutes
3 secondary outcomes
Mortality rate
Time frame: 6 months
Length of hospital stay
Time frame: 6 months
Complication rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus A. Küper, MD principal investigator
BG Trauma Center Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Ring Fracture and Pelvic Bleeding, run by BG Trauma Center Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for transfusion (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.