Condition category
Respiratory
Date applied
22/03/2016
Date assigned
24/03/2016
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Menoufia University Faculty of Medicine

Sponsor details

Yassin Abd Elghaffar Street
Shebin El-Kom
32513
Egypt

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes