Plain English Summary
Background and study aims
A pneumothorax is a serious condition in which air leaks into the space between the lung and the chest wall. This air pushes against the outside of the lung, causing it to collapse. Lung tissue that is damaged because of an underlying disease is more likely to develop pneumothorax as a complication (secondary spontaneous pneumothorax, SSP). When someone is suffering from SSP, it is very important to equalise the pressure in the chest so that the lungs can inflate properly. This is done by placing tubes into the space around the lungs in the chest (pleural cavity) so that any air can drain out of the chest (chest drainage). In some people, the air leak does not seal after chest drainage, and further treatment such as surgery is needed (persistent air leak). Persistent air leaks can be dangerous, as chest drains need to be left in place longer, which increases the risk of infection. Autologous blood patch pleurodesis is a technique in which the patient’s own blood is injected into the chest drain in order to “patch up” the air leak. The aim of this study is to investigate the effectiveness of early autologous blood-patch pleurodesis in the treatment of SSP.
Who can participate?
Adults with SSP who are unable or unwilling to have surgery.
What does the study involve?
After the chest drains are put in place, participants are randomly allocated to one of two groups. Those in the first group have 50ml of their own blood injected into the chest drain on day three. If the air leak continues, this procedure is repeated on day five and day seven. Participants in the second group do not receive any injections of their blood, and are observed in the usual manner for 10 days. After this, participants in this group can receive the autologous blood patch pleurodesis on day 10, 12 and 14. Over the 10 days of the study (before the second group are given the chance to have the procedure), participants in both groups are examined every day in order to find out if the air leak is sealed. Once the air lead has stopped, participants are kept under observation in hospital for one or two days before being discharged. The length of time until the air leak stops and until patients are discharged from hospital is recorded in both groups. Participants also attend a follow up appointment a week after they are discharged to make sure that the air leak is still sealed.
What are the possible benefits and risks of participating?
Participants may benefit from a quicker discharge from hospital. There are no notable risks of taking part in the study.
Where is the study run from?
Menoufia University Hospital (Egypt)
When is the study starting and how long is it expected to run for?
September 2012 to February 2016
Who is funding the study?
Menoufia University Faculty of Medicine (Egypt)
Who is the main contact?
Dr Islam Ibrahim
Trial website
Contact information
Type
Scientific
Primary contact
Dr Islam Ibrahim
ORCID ID
http://orcid.org/0000-0001-9293-5513
Contact details
Menoufia University Faculty of Medicine
Yassin Abdel Ghaffar Street
Shebin El-Kom
Menoufia
32513
Egypt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Early Autologous Blood-patch Pleurodesis versus Conservative Management for Treatment of Secondary spontaneous pneumothorax: a randomised controlled trial
Acronym
Study hypothesis
The aim of this study is to investigate whether early autologous blood-patch pleurodesis is better than conservative treatment for the management of secondary spontaneous pneumothorax.
Ethics approval
Ethics Committee - Menoufia University Faculty of Medicine, 03/10/2012
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Secondary spontaneous pneumothorax
Intervention
Following chest drain insertion, participants are randomly allocated to one of two groups.
Group 1: Participants have intra-pleural instillation of 50ml autologous blood into the chest drain on day 3 of chest drain insertion. If the air leak continues, the procedure is repeated on day 5 and day 7. Once the air leak has stopped the drain is removed after 1-2 days and the patient observed for 2-3 days before discharge from the hospital. Participants attend a follow up visit after 1 week in which they have a chest X-ray.
Group 2: Participants are observed for air leak for 10 days. If the air leak persists after 10 days, then participants receive the intra-pleural instillation of 50ml autologous blood into the chest drain, which can be repeated on day 12 and 14. Once the air leak has stopped the drain is removed after 1-2 days and the patient observed for 2-3 days before discharge from the hospital. Participants attend a follow up visit after 1 week in which they have a chest X-ray.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Time between insertion of chest drain and air leak stoppage is measured through daily clinical observations.
Secondary outcome measures
Length of hospital stay is measured in days.
Overall trial start date
01/09/2012
Overall trial end date
15/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years and over
2. Secondary spontaneous pneumothorax
3. Unfit or unwilling to have surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 - 50
Participant exclusion criteria
Not meeting the inclusion criteria.
Recruitment start date
01/11/2012
Recruitment end date
01/11/2015
Locations
Countries of recruitment
Egypt
Trial participating centre
Menoufia University Hospital
Gamal Abdel Nasser Street
Shibin Al Kawm
32513
Egypt
Funders
Funder type
University/education
Funder name
Menoufia University Faculty of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
30/04/2016
Participant level data
Available on request
Basic results (scientific)
Publication list