Hemothorax; TraumaticNCT03501524
VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
A study testing VATS evacuation and thoracostomy tube in people with Hemothorax; Traumatic, run by Assiut University at 1 site in Egypt.
Trial summary
This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemothorax; Traumatic
- What is being tested?
- VATS evacuation and thoracostomy tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Jul 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:
- Ages that are eligible for study are between 18years to 60 years (adult)
- Both genders will be included to study.
- Clinical and radiological diagnosis of persistent haemothorax.
- Thoracostomy tube blockage or failure to drain within 5-7days.
Who cannot join
- More than one thoracostomy tube drainage in the same attempt side.
- Unable to consent to trial.
- Coexisting pathology requiring other interventions.
- Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video_ Assisted Thoracoscopic Surgery Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. The most accepted complication of retained hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early withdrawal of tube thoracostomy which lead to more complications as empyema, fibro thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative treatment for retained hemothorax with evidence that it is a superior intervention when compared to a second tube thoracostomy.
Read the detailed description
Traumatic injuries are a significant cause of morbidity and mortality in our society.At Assiut university hospitals, chest injuries (17.7%) considered as second cause of mortality after head injuries (34.6%) of registered deaths by cause of injury at trauma unit, Assiut university hospitals in a study conducted between,2002-2009. In United States, thoracic injuries are the primary factor in approximately 35% of these deaths, one -third of which occur immediately following the injury, and are contributing in nearly 75% of trauma -related deaths. Up to 15% of patients who sustain thoracic trauma undergo emergent thoracotomy for resuscitation, massive hemothorax, cardiac tamponade, large thoracic wounds, major thoracic vascular injuries, tracheobronchial injuries, or evidence of esophageal injury. The remaining 85-90% of patients who reach the emergency department does not require emergent thoracotomy are initially managed with tube thoracostomy, pain control, pulmonary toilet, and observation .Patients failing this management ultimately require elective thoracotomy for further evaluation and treatment(clotted hemothorax, empyema and diaphragmatic hernia. The current role of VATS in trauma includes evaluation and control of continued chest tube bleeding, early evacuation of retained hemothorax, evacuation and decortication of posttraumatic empyemas, evaluation and limited treatment of suspected diaphragm injuries, evaluation and treatment of persistent air leaks, and evaluation of mediastinal injuries.
- Conditions
- Hemothorax; Traumatic
- Being tested
- VATS evacuation, thoracostomy tube
- Medical subject headings
- Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS evacuationDevice
the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax
thoracostomy tubeDevice
Also called intercostal tube reinsertion
the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
| Study group | Role | What they receive |
|---|---|---|
| VATS evacuation | Experimental | patients selected for VATS after failure of first thoracostomy tube drainage Receives: Device: VATS evacuation; Device: thoracostomy tube |
| thoracostomy tube | Experimental | patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube Receives: Device: VATS evacuation; Device: thoracostomy tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization
number of days spent
Measured: average 5-7 days
Secondary outcomes (1)
number of patients developed empyema
the study will be monitored for septic complications , specially empyema.
Measured: through one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jul 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemothorax; TraumaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Emad El-Dein Omar, Assiut University
- Investigators
- Mohammed Khalil salama Ayyad, PHD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501524
- Sponsor's protocol ID
- 17100227
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2018
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video_ Assisted Thoracoscopic Surgery Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
- ClinicalTrials.gov ID
- NCT03501524
- Acronym / sponsor ID
- 17100227
- Conditions
- Hemothorax; Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 18 Apr 2018 (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.
This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. The most accepted complication of retained hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early withdrawal of tube thoracostomy which lead to more complications as empyema, fibro thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative treatment for retained hemothorax with evidence that it is a superior intervention when compared to a second tube thoracostomy.
Detailed description
Traumatic injuries are a significant cause of morbidity and mortality in our society.At Assiut university hospitals, chest injuries (17.7%) considered as second cause of mortality after head injuries (34.6%) of registered deaths by cause of injury at trauma unit, Assiut university hospitals in a study conducted between,2002-2009. In United States, thoracic injuries are the primary factor in approximately 35% of these deaths, one -third of which occur immediately following the injury, and are contributing in nearly 75% of trauma -related deaths. Up to 15% of patients who sustain thoracic trauma undergo emergent thoracotomy for resuscitation, massive hemothorax, cardiac tamponade, large thoracic wounds, major thoracic vascular injuries, tracheobronchial injuries, or evidence of esophageal injury. The remaining 85-90% of patients who reach the emergency department does not require emergent thoracotomy are initially managed with tube thoracostomy, pain control, pulmonary toilet, and observation .Patients failing this management ultimately require elective thoracotomy for further evaluation and treatment(clotted hemothorax, empyema and diaphragmatic hernia. The current role of VATS in trauma includes evaluation and control of continued chest tube bleeding, early evacuation of retained hemothorax, evacuation and decortication of posttraumatic empyemas, evaluation and limited treatment of suspected diaphragm injuries, evaluation and treatment of persistent air leaks, and evaluation of mediastinal injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS evacuation | Experimental | Device: VATS evacuation, Device: thoracostomy tubepatients selected for VATS after failure of first thoracostomy tube drainage |
| thoracostomy tube | Experimental | Device: VATS evacuation, Device: thoracostomy tubepatients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:
- Ages that are eligible for study are between 18years to 60 years (adult)
- Both genders will be included to study.
- Clinical and radiological diagnosis of persistent haemothorax.
- Thoracostomy tube blockage or failure to drain within 5-7days.
Key exclusion criteria (4 listed)
- More than one thoracostomy tube drainage in the same attempt side.
- Unable to consent to trial.
- Coexisting pathology requiring other interventions.
- Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).
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 |
|---|---|---|
| VATS evacuationthe patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax | Device | VATS evacuation, thoracostomy tube |
| thoracostomy tubeAlso: intercostal tube reinsertionthe patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax | Device | VATS evacuation, thoracostomy tube |
Primary outcome
Duration of hospitalization
Time frame: average 5-7 days
number of days spent
1 secondary outcome
number of patients developed empyema
Time frame: through one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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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.
Mohammed Khalil salama Ayyad, PHD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VATS evacuation and thoracostomy tube in people with Hemothorax; Traumatic, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospitalization (time frame: average 5-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.