search
Back to results

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

Primary Purpose

Trauma, Pelvic Fracture, Hemodynamic Instability

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Angioembolization
Preperitoneal Pelvic Packing
Sponsored by
Nuria Llorach-Perucho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Trauma, Pelvis Fracture, Hypovolemic Shock, Preperitoneal Pelvic Packing, Angioembolization, Hemodynamic Instability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Corporació Sanitària Parc Taulí

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Angioembolization

Preperitoneal Pelvic Packing

Arm Description

Outcomes

Primary Outcome Measures

Pelvic bleeding control based on clinical response
Clinical response after the intervention

Secondary Outcome Measures

Additional techniques
Need for additional techniques after the intervention to control bleeding associated with pelvic fracture
Post-procedure complications
Presence of post-procedure complications
Post-procedure complications degree
Description of post-procedure complications: Clavien Dindo scale
Post-procedure complications degree
Description of post-procedure complications: Comprehensive Complication Index
Mortality
Death of the pacient (cause and date)
Blood cell transfusion
Need for blood cell transfusion for patients (number and need for masive transfusion protocol activation)
Time until intervention
Time elapsed between hospital admission and intervention

Full Information

First Posted
February 16, 2021
Last Updated
January 4, 2022
Sponsor
Nuria Llorach-Perucho
Collaborators
Corporacion Parc Tauli
search

1. Study Identification

Unique Protocol Identification Number
NCT04764864
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No financing
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nuria Llorach-Perucho
Collaborators
Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Pelvic Fracture, Hemodynamic Instability
Keywords
Trauma, Pelvis Fracture, Hypovolemic Shock, Preperitoneal Pelvic Packing, Angioembolization, Hemodynamic Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angioembolization
Arm Type
Active Comparator
Arm Title
Preperitoneal Pelvic Packing
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Angioembolization
Intervention Description
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
Intervention Name(s)
Preperitoneal Pelvic Packing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic bleeding control based on clinical response
Description
Clinical response after the intervention
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Additional techniques
Description
Need for additional techniques after the intervention to control bleeding associated with pelvic fracture
Time Frame
Through study completion, an average of 2 years
Title
Post-procedure complications
Description
Presence of post-procedure complications
Time Frame
Through study completion, an average of 2 years
Title
Post-procedure complications degree
Description
Description of post-procedure complications: Clavien Dindo scale
Time Frame
Through study completion, an average of 2 years
Title
Post-procedure complications degree
Description
Description of post-procedure complications: Comprehensive Complication Index
Time Frame
Through study completion, an average of 2 years
Title
Mortality
Description
Death of the pacient (cause and date)
Time Frame
Through study completion, an average of 2 years
Title
Blood cell transfusion
Description
Need for blood cell transfusion for patients (number and need for masive transfusion protocol activation)
Time Frame
Through study completion, an average of 2 years
Title
Time until intervention
Description
Time elapsed between hospital admission and intervention
Time Frame
Time until intervention (up to 60 minutes)
Other Pre-specified Outcome Measures:
Title
Time until arrival at hospital
Description
Time elapsed between prehospital attention and hospital admission
Time Frame
Time until arrival at hospital (up to 30 minutes)
Title
Duration of angioembolization
Description
Duration of angioembolization
Time Frame
Through study completion, an average of 2 years
Title
Angioembolization treatment
Description
Arteries treated with angioembolization
Time Frame
Through study completion, an average of 2 years
Title
Duration of Preperitoneal Pelvic Packing
Description
Duration of Preperitoneal Pelvic Packing
Time Frame
Through study completion, an average of 2 years
Title
Intensive care unit stay
Description
Number of days that the patient remains in the intensive care unit
Time Frame
Through study completion, an average of 2 years
Title
Hospital stay
Description
Number of days that the patient remains in hospital
Time Frame
Through study completion, an average of 2 years
Title
Readmission
Description
Readmission 30 days after discharge
Time Frame
30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria Llorach-Perucho, MD
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salvador Navarro-Soto, MD, PhD
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrea Campos-Serra, MD
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Study Director
Facility Information:
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs