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

NCT04764864 | Withdrawn

• 1 other identifier: PELVITRAU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Pelvic Fracture; Hemodynamic Instability

Keywords

Trauma; Pelvis Fracture; Hypovolemic Shock; Preperitoneal Pelvic Packing; Angioembolization; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Pelvic bleeding control based on clinical response

  Clinical response after the intervention

  24 hours

Secondary Outcomes (7)

• Additional techniques

  Through study completion, an average of 2 years

• Post-procedure complications

  Through study completion, an average of 2 years

• Post-procedure complications degree

  Through study completion, an average of 2 years

• Post-procedure complications degree

  Through study completion, an average of 2 years

• Mortality

  Through study completion, an average of 2 years

Other Outcomes (7)

• Time until arrival at hospital

  Time until arrival at hospital (up to 30 minutes)

• Duration of angioembolization

  Through study completion, an average of 2 years

• Angioembolization treatment

  Through study completion, an average of 2 years

Study Arms (2)

Angioembolization

ACTIVE COMPARATOR

Procedure: Angioembolization

Preperitoneal Pelvic Packing

ACTIVE COMPARATOR

Procedure: Preperitoneal Pelvic Packing

Interventions

Angioembolization PROCEDURE

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.

Angioembolization

Preperitoneal Pelvic Packing PROCEDURE

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.

Preperitoneal Pelvic Packing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other causes of bleeding that require treatment

Sponsors & Collaborators

• Nuria Llorach-Perucho: lead
• Corporacion Parc Tauli: collaborator

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries; Hip Fractures; Shock

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuria Llorach-Perucho, MD

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

• Salvador Navarro-Soto, MD, PhD

  Corporacion Parc Tauli

  STUDY DIRECTOR

• Andrea Campos-Serra, MD

  Corporacion Parc Tauli

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

ES (1)