TraumaNCT04764864
Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
A study testing Angioembolization and Preperitoneal Pelvic Packing in people with Trauma and Pelvic Fracture, run by Nuria Llorach-Perucho at 1 site in Spain.
Trial summary
Pelvic fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Pelvic Fracture, Hemodynamic Instability
- What is being tested?
- Angioembolization and Preperitoneal Pelvic Packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 1 Jan 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure ≤ 90 mmHg
- Heart rate > 100 bpm
- Shock Index ≥ 0,8
- Pelvic fracture
- Negative FAST / peritoneal aspiration
Who cannot join
- Other causes of bleeding that require treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
Pelvic fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. Nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. Consequently, it is important to define better the management of these patients.
This investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. Unstable trauma patients with a pelvic fracture and no other injuries (negative FAST / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. There will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the Intensive Care Unit). Registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality.
The objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.
- Conditions
- Trauma, Pelvic Fracture, Hemodynamic Instability
- Being tested
- Angioembolization, Preperitoneal Pelvic Packing
- Keywords
- Trauma, Pelvis Fracture, Hypovolemic Shock, Preperitoneal Pelvic Packing, Angioembolization, Hemodynamic Instability
- Medical subject headings
- Wounds and Injuries, Hip Fractures, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioembolizationProcedure or surgery
Via the femoral route, a non-selective pelvic arteriography with a selective embolization of the arterial branches that show direct or indirect signs of injury will be performed.
In the event of persistent hemodynamic instability after selective embolization, non-selective bilateral embolization of the internal iliac arteries will be evaluated.
The material used will vary depending on the characteristics of the injury and the availability of the materials.
Preperitoneal Pelvic PackingProcedure or surgery
Pfannestiel incision / infraumbilical laparotomy. Dissection of tissues up to and including the transversalis fascia. Inferior to this and anterior to the peritoneum, the preperitoneal cavity is identified.
Inclusion of radiopaque laparotomy gauze in each hemipelvis, from the posterior part (anterior to the sacro-iliac joint) to the most anterior in the retropubic position. Subsequently, the closure is carried out to increase the plugging effect.
A second intervention is required to remove the material in 24-48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Angioembolization | Active comparator | Not described Receives: Procedure: Angioembolization |
| Preperitoneal Pelvic Packing | Active comparator | Not described Receives: Procedure: Preperitoneal Pelvic Packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic bleeding control based on clinical response
Clinical response after the intervention
Measured: 24 hours
Secondary outcomes (7)
Additional techniques
Need for additional techniques after the intervention to control bleeding associated with pelvic fracture
Measured: Through study completion, an average of 2 years
Post-procedure complications
Presence of post-procedure complications
Measured: Through study completion, an average of 2 years
Post-procedure complications degree
Description of post-procedure complications: Clavien Dindo scale
Measured: Through study completion, an average of 2 years
Post-procedure complications degree
Description of post-procedure complications: Comprehensive Complication Index
Measured: Through study completion, an average of 2 years
Mortality
Death of the pacient (cause and date)
Measured: Through study completion, an average of 2 years
Blood cell transfusion
Need for blood cell transfusion for patients (number and need for masive transfusion protocol activation)
Measured: Through study completion, an average of 2 years
Time until intervention
Time elapsed between hospital admission and intervention
Measured: Time until intervention (up to 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: No financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuria Llorach-Perucho
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Sponsor-investigator, Nuria Llorach-Perucho, Corporacion Parc Tauli
- Investigators
- Nuria Llorach-Perucho, MD, Principal investigator, Corporacion Parc TauliSalvador Navarro-Soto, MD, PhD, Study director, Corporacion Parc TauliAndrea Campos-Serra, MD, Study director, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764864
- Sponsor's protocol ID
- PELVITRAU
- Status last verified
- Jan 2022
- First submitted
- 16 Feb 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
- ClinicalTrials.gov ID
- NCT04764864
- Acronym / sponsor ID
- PELVITRAU
- Conditions
- Trauma, Pelvic Fracture, Hemodynamic Instability
- Keywords
- Trauma, Pelvis Fracture, Hypovolemic Shock, Preperitoneal Pelvic Packing, Angioembolization, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nuria Llorach-PeruchoUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 21 Feb 2021 (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 fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. Nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. Consequently, it is important to define better the management of these patients.
This investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. Unstable trauma patients with a pelvic fracture and no other injuries (negative FAST / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. There will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the Intensive Care Unit). Registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality.
The objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angioembolization | Active comparator | Procedure: Angioembolization |
| Preperitoneal Pelvic Packing | Active comparator | Procedure: Preperitoneal Pelvic Packing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systolic blood pressure ≤ 90 mmHg
- Heart rate > 100 bpm
- Shock Index ≥ 0,8
- Pelvic fracture
- Negative FAST / peritoneal aspiration
Key exclusion criteria (1 listed)
- Other causes of bleeding that require treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioembolizationVia the femoral route, a non-selective pelvic arteriography with a selective embolization of the arterial branches that show direct or indirect signs of injury will be performed. In the event of persistent hemodynamic instability after selective embolization, non-selective bilateral embolization of the internal iliac arteries will be evaluated. The material used will vary depending on the characteristics of the injury and the availability of the materials. | Procedure or surgery | Angioembolization |
| Preperitoneal Pelvic PackingPfannestiel incision / infraumbilical laparotomy. Dissection of tissues up to and including the transversalis fascia. Inferior to this and anterior to the peritoneum, the preperitoneal cavity is identified. Inclusion of radiopaque laparotomy gauze in each hemipelvis, from the posterior part (anterior to the sacro-iliac joint) to the most anterior in the retropubic position. Subsequently, the closure is carried out to increase the plugging effect. A second intervention is required to remove the material in 24-48 hours. | Procedure or surgery | Preperitoneal Pelvic Packing |
Primary outcome
Pelvic bleeding control based on clinical response
Time frame: 24 hours
Clinical response after the intervention
7 secondary outcomes
Additional techniques
Time frame: Through study completion, an average of 2 years
Post-procedure complications
Time frame: Through study completion, an average of 2 years
Post-procedure complications degree
Time frame: Through study completion, an average of 2 years
Post-procedure complications degree
Time frame: Through study completion, an average of 2 years
Mortality
Time frame: Through study completion, an average of 2 years
Blood cell transfusion
Time frame: Through study completion, an average of 2 years
Time until intervention
Time frame: Time until intervention (up to 60 minutes)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
Nuria Llorach-Perucho, MD principal investigator
Corporacion Parc Tauli
Salvador Navarro-Soto, MD, PhD study director
Corporacion Parc Tauli
Andrea Campos-Serra, MD study director
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioembolization and Preperitoneal Pelvic Packing in people with Trauma and Pelvic Fracture, run by Nuria Llorach-Perucho at 1 site in Spain.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Jan 2022. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pelvic bleeding control based on clinical response (time frame: 24 hours). 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 19 Jan 2022.