NCT04917198

Brief Summary

The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 20, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

May 20, 2021

Last Update Submit

June 1, 2021

Conditions

Trauma Chest

Outcome Measures

Primary Outcomes (1)

  • Time needed to explore heart

    To reveal time needed to explore heart in both interventions.

    baseline

Secondary Outcomes (1)

  • Pain by pain score

    baseline

Study Arms (1)

median sternotomy

EXPERIMENTAL

median sternotomy in penetrating cardiac trauma and hemodynamically unstable patients, does it affect morbidity and mortality.

Procedure: median sternotomy

Interventions

median sternotomyPROCEDURE

median sternotomy

median sternotomy

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Penetrating traumatic cardiac patients. B.age:patients aged from15 to 60 years old.

You may not qualify if:

  • Patient who arrest immediately when arrived trauma unit.
  • patients with polytrauma
  • patients with chronic medical disease as asthma or ischemic herat disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Gosavi S, Tyroch AH, Mukherjee D. Cardiac Trauma. Angiology. 2016 Nov;67(10):896-901. doi: 10.1177/0003319715627954. Epub 2016 Jul 11.

    PMID: 26802100BACKGROUND

  • Leite L, Goncalves L, Nuno Vieira D. Cardiac injuries caused by trauma: Review and case reports. J Forensic Leg Med. 2017 Nov;52:30-34. doi: 10.1016/j.jflm.2017.08.013. Epub 2017 Aug 24.

    PMID: 28850860BACKGROUND

  • Rahim Khan HA, Gilani JA, Pervez MB, Hashmi S, Hasan S. Penetrating cardiac trauma: A retrospective case series from Karachi. J Pak Med Assoc. 2018 Aug;68(8):1285-1287.

    PMID: 30108408BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries

Interventions

Sternotomy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Ahmed Gadallah

CONTACT

+201067172284ahmedgadallah629@gmail.com

Mohamed Mahmoud

CONTACT

+201008332462mohamedmahmoud@aun.edu.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Median sternotomy in penetrating cardiac trauma , does it make a difference?

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 8, 2021

Study Start

December 21, 2021

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

June 8, 2021

Record last verified: 2021-06