Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

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.

Study Overview

• Status: Withdrawn
• Conditions: Trauma; Pelvic Fracture; Hemodynamic Instability
• Intervention / Treatment: Procedure: Angioembolization; Procedure: Preperitoneal Pelvic Packing

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Angioembolization	Procedure: Angioembolization; 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.
ACTIVE_COMPARATOR: Preperitoneal Pelvic Packing	Procedure: Preperitoneal Pelvic Packing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic bleeding control based on clinical response	Clinical response after the intervention	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional techniques	Need for additional techniques after the intervention to control bleeding associated with pelvic fracture	Through study completion, an average of 2 years
Post-procedure complications	Presence of post-procedure complications	Through study completion, an average of 2 years
Post-procedure complications degree	Description of post-procedure complications: Clavien Dindo scale	Through study completion, an average of 2 years
Post-procedure complications degree	Description of post-procedure complications: Comprehensive Complication Index	Through study completion, an average of 2 years
Mortality	Death of the pacient (cause and date)	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)	Through study completion, an average of 2 years
Time until intervention	Time elapsed between hospital admission and intervention	Time until intervention (up to 60 minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until arrival at hospital	Time elapsed between prehospital attention and hospital admission	Time until arrival at hospital (up to 30 minutes)
Duration of angioembolization	Duration of angioembolization	Through study completion, an average of 2 years
Angioembolization treatment	Arteries treated with angioembolization	Through study completion, an average of 2 years
Duration of Preperitoneal Pelvic Packing	Duration of Preperitoneal Pelvic Packing	Through study completion, an average of 2 years
Intensive care unit stay	Number of days that the patient remains in the intensive care unit	Through study completion, an average of 2 years
Hospital stay	Number of days that the patient remains in hospital	Through study completion, an average of 2 years
Readmission	Readmission 30 days after discharge	30 days after discharge

Collaborators and Investigators

• Sponsor: Nuria Llorach-Perucho
• Collaborators: Corporacion Parc Tauli
• Investigators: Study Director: Andrea Campos-Serra, MD, Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Trauma; Hypovolemic Shock; Pelvis Fracture; Preperitoneal Pelvic Packing; Angioembolization; Hemodynamic Instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PELVITRAU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No