NCT05944003

Brief Summary

Resuscitative thoracotomies (RT) are an effective life saving measure in appropriate populations \[1-8\]. Unfortunately, when used outside of these populations the mortality rate is typically more than 90% \[1-8\]. Western Trauma Association and Eastern Association for the Surgery of Trauma have provided guidelines for which trauma patients are a candidate for RT \[1-3\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
Last Updated

June 10, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

July 6, 2023

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total number of RT (before and during the COVID-19 pandemic)

    Determine the rate of RT at MDMC. Particularly, if there was an increase during the COVID-19 pandemic, which would lead to greater exposure to transmissible disease

    2 years

Secondary Outcomes (1)

  • • Cognitive deficits of any survivors of RT (GCS, assessments by neurology, mental status exams, and/or similar assessments documented in the EMR)

    2 yrs

Interventions

Resuscitative thoracotomies is an effective life saving measure in appropriate populations \[1-8\]. Unfortunately, when used outside of these populations the mortality rate is typically more than 90% \[1-8\]. Western Trauma Association and Eastern Association for the Surgery of Trauma have provided guidelines for which trauma patients are a candidate for RT \[1-

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trauma patients who underwent RT in the emergency department (ED), operating room (OR), or intensive care unit (ICU) from January 1, 2017 to December 31, 2023.

You may qualify if:

  • Trauma patients who underwent RT in the emergency department (ED), operating room (OR), or intensive care unit (ICU) from January 1, 2017 to December 31, 2023.

You may not qualify if:

  • Trauma patients who did not have a RT in the ED, OR, or ICU or were less than 16 years old from January 1, 2017 to December 31, 2023.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Related Publications (10)

  • Burlew CC, Moore EE, Moore FA, Coimbra R, McIntyre RC Jr, Davis JW, Sperry J, Biffl WL. Western Trauma Association critical decisions in trauma: resuscitative thoracotomy. J Trauma Acute Care Surg. 2012 Dec;73(6):1359-63. doi: 10.1097/TA.0b013e318270d2df.

    PMID: 23188227BACKGROUND
  • Moore EE, Knudson MM, Burlew CC, Inaba K, Dicker RA, Biffl WL, Malhotra AK, Schreiber MA, Browder TD, Coimbra R, Gonzalez EA, Meredith JW, Livingston DH, Kaups KL; WTA Study Group. Defining the limits of resuscitative emergency department thoracotomy: a contemporary Western Trauma Association perspective. J Trauma. 2011 Feb;70(2):334-9. doi: 10.1097/TA.0b013e3182077c35.

    PMID: 21307731BACKGROUND
  • Seamon MJ, Haut ER, Van Arendonk K, Barbosa RR, Chiu WC, Dente CJ, Fox N, Jawa RS, Khwaja K, Lee JK, Magnotti LJ, Mayglothling JA, McDonald AA, Rowell S, To KB, Falck-Ytter Y, Rhee P. An evidence-based approach to patient selection for emergency department thoracotomy: A practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2015 Jul;79(1):159-73. doi: 10.1097/TA.0000000000000648.

    PMID: 26091330BACKGROUND
  • Aseni P, Rizzetto F, Grande AM, Bini R, Sammartano F, Vezzulli F, Vertemati M. Emergency Department Resuscitative Thoracotomy: Indications, surgical procedure and outcome. A narrative review. Am J Surg. 2021 May;221(5):1082-1092. doi: 10.1016/j.amjsurg.2020.09.038. Epub 2020 Oct 2.

    PMID: 33032791BACKGROUND
  • Hughes M, Perkins Z. Outcomes following resuscitative thoracotomy for abdominal exsanguination, a systematic review. Scand J Trauma Resusc Emerg Med. 2020 Feb 6;28(1):9. doi: 10.1186/s13049-020-0705-4.

    PMID: 32028977BACKGROUND
  • Rhee PM, Acosta J, Bridgeman A, Wang D, Jordan M, Rich N. Survival after emergency department thoracotomy: review of published data from the past 25 years. J Am Coll Surg. 2000 Mar;190(3):288-98. doi: 10.1016/s1072-7515(99)00233-1.

    PMID: 10703853BACKGROUND
  • Powell DW, Moore EE, Cothren CC, Ciesla DJ, Burch JM, Moore JB, Johnson JL. Is emergency department resuscitative thoracotomy futile care for the critically injured patient requiring prehospital cardiopulmonary resuscitation? J Am Coll Surg. 2004 Aug;199(2):211-5. doi: 10.1016/j.jamcollsurg.2004.04.004.

    PMID: 15275875BACKGROUND
  • Panossian VS, Nederpelt CJ, El Hechi MW, Chang DC, Mendoza AE, Saillant NN, Velmahos GC, Kaafarani HMA. Emergency Resuscitative Thoracotomy: A Nationwide Analysis of Outcomes and Predictors of Futility. J Surg Res. 2020 Nov;255:486-494. doi: 10.1016/j.jss.2020.05.048. Epub 2020 Jul 1.

    PMID: 32622163BACKGROUND
  • Inaba K, Chouliaras K, Zakaluzny S, Swadron S, Mailhot T, Seif D, Teixeira P, Sivrikoz E, Ives C, Barmparas G, Koronakis N, Demetriades D. FAST ultrasound examination as a predictor of outcomes after resuscitative thoracotomy: a prospective evaluation. Ann Surg. 2015 Sep;262(3):512-8; discussion 516-8. doi: 10.1097/SLA.0000000000001421.

    PMID: 26258320BACKGROUND
  • Soreide K, Petrone P, Asensio JA. Emergency thoracotomy in trauma: rationale, risks, and realities. Scand J Surg. 2007;96(1):4-10. doi: 10.1177/145749690709600102.

    PMID: 17461305BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 13, 2023

Study Start

May 18, 2022

Primary Completion

September 10, 2025

Study Completion

September 18, 2025

Last Updated

June 10, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
with in 1-2 years
Access Criteria
The data will be presented at local, regional, national, and international sites. The research gathered will be analyzed and submitted to relevant peer-reviewed medical journals for publication to add to the body of knowledge in the science community. Our potential list of conferences include: AAST (American Association for the Surgery of Trauma), SWSC (Southwest Surgical Congress), Eastern Association for the Surgery of Trauma, WTA (Western Trauma Association), or similar.

Locations