Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury

NCT01852773 | Withdrawn DMC

• 1 other identifier: IRB-11-5736
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to increase understanding of the short-term and long-term outcome of blunt aortic injury (BAI) and to discern if there is an advantage resulting from the type of operative treatment used to manage it, either the classic open surgical repair or a newer technique known as thoracic endovascular repair (TEVAR). Specifically, this study will answer the following questions regarding patients suffering BAI:

1. 1.What clinical variables affect short-term mortality and neurologic outcome?
2. 2.What are the long-term treatment-associated complications of open repair and TEVAR?
3. 3.In patients with a similar injury and physiologic profile, is there a survival advantage resulting from the type of operative treatment?

Conditions

Blunt Injury

Keywords

blunt; injury; aorta; endovascular

Outcome Measures

Primary Outcomes (1)

• Short-Term Mortality

  Cause of death during the index hospitalization (prior to discharge, averaging less than 30 days from the time of injury) will be assessed, as measured by death certificate and autopsy or, if no autopsy, morbidity and mortality review findings. Care withdrawn at request of family will also be noted. Final adjudication of mortality (preventable, non-preventable, or possibly preventable)will be gathered.

  During the index hospitalization, an expected average of 30 days from time of injury

Secondary Outcomes (2)

• Short-Term Treatment-Associated Complications

  During the index hospitalization, an expected average of 30 days from time of injury

• Long-Term Treatment-Associated Complications

  Up to 5 years following discharge

Study Arms (1)

Blunt Aortic Injury Patients

Trauma patients with blunt aortic injury. This Cohort of trauma patients will require management with one of two interventions. They will require either; Open repair of thoracic aorta injury (Intervention #1) or TEVAR (Intervention #2). As of yet the short term and long term outcomes of these two treatments have not been directly compared.

Procedure: Open repair of thoracic aorta injury; Procedure: TEVAR

Interventions

Open repair of thoracic aorta injury PROCEDURE

open surgical management of aortic injury

Also known as: Open chest repair of injured aorta

Blunt Aortic Injury Patients

TEVAR PROCEDURE

Use of endovascular (minimally invasive) techniques for repair of aortic injury

Also known as: Thoracic endovascular aortic repair

Blunt Aortic Injury Patients

Eligibility Criteria

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

Study Population

Trauma patients with blunt aortic injury (BAI)

You may qualify if:

• Clinical diagnosis of blunt aortic injury (BAI)

You may not qualify if:

• Clinical diagnosis of penetrating aortic injury

Sponsors & Collaborators

• Scripps Health: lead
• Western Trauma Association: collaborator

Study Sites (1)

Scripps Mercy Hospital

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Wounds, Nonpenetrating; Wounds and Injuries

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Steven R Shackford, MD

  Scripps Mercy Hospital, Division of Trauma Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: May 14, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

US (1)