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

NCT ID: NCT04764864

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angioembolization

Group Type: ACTIVE_COMPARATOR

Angioembolization

Intervention Type: 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.

Preperitoneal Pelvic Packing

Group Type: ACTIVE_COMPARATOR

Preperitoneal Pelvic Packing

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: collaborator

Nuria Llorach-Perucho

OTHER

Sponsor Role: lead

Responsible Party

Nuria Llorach-Perucho

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nuria Llorach-Perucho, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Salvador Navarro-Soto, MD, PhD

Role: STUDY_DIRECTOR

Corporacion Parc Tauli

Andrea Campos-Serra, MD

Role: STUDY_DIRECTOR

Corporacion Parc Tauli

Locations

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

PELVITRAU

Identifier Type: -

Identifier Source: org_study_id