Trauma ChestNCT04917198
Median Sternotomy in Penetrating Cardiac Trauma
A study testing median sternotomy in people with Trauma Chest, run by Assiut University.
Trial summary
The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Trauma Chest
- What is being tested?
- median sternotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A. Inclusion criteria:
- Penetrating traumatic cardiac patients. B.age:patients aged from15 to 60 years old.
Who cannot join
- Patient who arrest immediately when arrived trauma unit.
- patients with polytrauma
- patients with chronic medical disease as asthma or ischemic herat disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Median Sternotomy in Penetrating Cardiac Trauma Does it Make a Difference?
The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients.
Read the detailed description
Cardiac trauma is a leading cause of death in the USA and occurs mostly due to motor vehicle accidents. Cardiac trauma may be blunt or as a penetrating chest injuries, and both can lead to aortic injuries. The Right Ventricle followed by the Left Ventricle was the most common site of injury.
Timely diagnosis and early management are the key to improve mortality. Mortality related to cardiac trauma remains high despite improvement in diagnosis and management.
Assessment of suspected cardiac injuries in a trauma setting is a challenging and time-critical matter, with clinical and imaging findings having complementary roles in the formation of an accurate diagnosis. Cardiac computed tomography and cardiac ultrasound are the two most important diagnostic modalities.
Pericardial tamponade and haemothorax were common intra-operative findings. Patients having penetrating cardiac injury presenting with detectable signs of life on arrival to the hospital can be rescued by early surgical intervention.
Penetrating cardiac injuries are high-risk, high-mortality injuries considering the outcomes. Therefore, it is important to choose the appropriate incision. In general clinical settings, thoracotomy and median sternotomy are choices of incisions to explore the injury.
It is really important to transfer these patients to the nearest facility in time, make sure they get immediate diagnosis and proper resuscitation until they are ready to be taken into the operating room for exploration.
- Conditions
- Trauma Chest
- Being tested
- median sternotomy
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
median sternotomyProcedure or surgery
median sternotomy
| Study group | Role | What they receive |
|---|---|---|
| median sternotomy | Experimental | median sternotomy in penetrating cardiac trauma and hemodynamically unstable patients, does it affect morbidity and mortality. Receives: Procedure: median sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed to explore heart
To reveal time needed to explore heart in both interventions.
Measured: baseline
Secondary outcomes (1)
Pain by pain score
Post operative pain complained by patient.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start21 Dec 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trauma ChestStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Gadallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917198
- Sponsor's protocol ID
- Median sternotomy
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gosavi S, Tyroch AH, Mukherjee D. Cardiac Trauma. Angiology. 2016 Nov;67(10):896-901. doi: 10.1177/0003319715627954. Epub 2016 Jul 11.
PubMed 26802100Leite 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.
PubMed 28850860Rahim 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.
PubMed 30108408
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Sternotomy in Penetrating Cardiac Trauma Does it Make a Difference?
- ClinicalTrials.gov ID
- NCT04917198
- Acronym / sponsor ID
- Median sternotomy
- Conditions
- Trauma Chest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients.
Detailed description
Cardiac trauma is a leading cause of death in the USA and occurs mostly due to motor vehicle accidents. Cardiac trauma may be blunt or as a penetrating chest injuries, and both can lead to aortic injuries. The Right Ventricle followed by the Left Ventricle was the most common site of injury.
Timely diagnosis and early management are the key to improve mortality. Mortality related to cardiac trauma remains high despite improvement in diagnosis and management.
Assessment of suspected cardiac injuries in a trauma setting is a challenging and time-critical matter, with clinical and imaging findings having complementary roles in the formation of an accurate diagnosis. Cardiac computed tomography and cardiac ultrasound are the two most important diagnostic modalities.
Pericardial tamponade and haemothorax were common intra-operative findings. Patients having penetrating cardiac injury presenting with detectable signs of life on arrival to the hospital can be rescued by early surgical intervention.
Penetrating cardiac injuries are high-risk, high-mortality injuries considering the outcomes. Therefore, it is important to choose the appropriate incision. In general clinical settings, thoracotomy and median sternotomy are choices of incisions to explore the injury.
It is really important to transfer these patients to the nearest facility in time, make sure they get immediate diagnosis and proper resuscitation until they are ready to be taken into the operating room for exploration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| median sternotomy | Experimental | Procedure: median sternotomymedian sternotomy in penetrating cardiac trauma and hemodynamically unstable patients, does it affect morbidity and mortality. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- A. Inclusion criteria:
- Penetrating traumatic cardiac patients. B.age:patients aged from15 to 60 years old.
Key exclusion criteria (3 listed)
- Patient who arrest immediately when arrived trauma unit.
- patients with polytrauma
- patients with chronic medical disease as asthma or ischemic herat disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| median sternotomymedian sternotomy | Procedure or surgery | median sternotomy |
Primary outcome
Time needed to explore heart
Time frame: baseline
To reveal time needed to explore heart in both interventions.
1 secondary outcome
Pain by pain score
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 26802100Gosavi S, Tyroch AH, Mukherjee D. Cardiac Trauma. Angiology. 2016 Nov;67(10):896-901. doi: 10.1177/0003319715627954. Epub 2016 Jul 11.
- Background: PubMed 28850860Leite 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.
- Background: PubMed 30108408Rahim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing median sternotomy in people with Trauma Chest, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Gadallah (+201067172284, ahmedgadallah629@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time needed to explore heart (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917198, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.