Clinical trial NCT04764864: Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
Official title: Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trauma
Pelvic Fracture
Hemodynamic Instability
Keywords: Trauma
Pelvis Fracture
Hypovolemic Shock
Preperitoneal Pelvic Packing
Angioembolization
Hemodynamic Instability
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure ≤ 90 mmHg
* Heart rate \> 100 bpm
* Shock Index ≥ 0,8
* Pelvic fracture
* Negative FAST / peritoneal aspiration

Exclusion Criteria:

* Other causes of bleeding that require treatment

Primary outcomes:
measure: Pelvic bleeding control based on clinical response
timeFrame: 24 hours
Secondary outcomes:
measure: Additional techniques
timeFrame: Through study completion, an average of 2 years
measure: Post-procedure complications
timeFrame: Through study completion, an average of 2 years
measure: Post-procedure complications degree
timeFrame: Through study completion, an average of 2 years
measure: Post-procedure complications degree
timeFrame: Through study completion, an average of 2 years
measure: Mortality
timeFrame: Through study completion, an average of 2 years
measure: Blood cell transfusion
timeFrame: Through study completion, an average of 2 years
measure: Time until intervention
timeFrame: Time until intervention (up to 60 minutes)
Other outcomes:
measure: Time until arrival at hospital
timeFrame: Time until arrival at hospital (up to 30 minutes)
measure: Duration of angioembolization
timeFrame: Through study completion, an average of 2 years
measure: Angioembolization treatment
timeFrame: Through study completion, an average of 2 years
measure: Duration of Preperitoneal Pelvic Packing
timeFrame: Through study completion, an average of 2 years
measure: Intensive care unit stay
timeFrame: Through study completion, an average of 2 years
measure: Hospital stay
timeFrame: Through study completion, an average of 2 years
measure: Readmission
timeFrame: 30 days after discharge
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Nuria Llorach-Perucho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacion Parc Tauli
name: Salvador Navarro-Soto, MD, PhD
role: STUDY_DIRECTOR
affiliation: Corporacion Parc Tauli
name: Andrea Campos-Serra, MD
role: STUDY_DIRECTOR
References: