Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505753650802 Date of Registration: 06/05/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does combined doxycycline and autologous blood patch more effective autologous blood patch alone for management of persistent air leak in patients with secondary spontaneous pneumothorax : A randomized control trial
Official scientific title Efficacy of combined doxycycline and autologous blood patch versus autologous blood patch alone for management of persistent air leak in patients with secondary spontaneous pneumothorax : A randomized control trial
Brief summary describing the background and objectives of the trial Spontaneous pneumothorax, defined as the presence of air in the pleural space without a preceding trauma, and can be classified as primary or secondary based on the lung parenchymal involvement. Secondary spontaneous pneumothorax (SSP) presents as a complication of underlying lung disease (1). The common underlying causes for the secondary spontaneous pneumothorax includes chronic obstructive pulmonary disease (COPD), tuberculosis (TB), human immunodeficiency virus (HIV), cystic fibrosis, and smoking (2). Studies observed that persistent air leak (PAL) for 5 to 7 days in patients with secondary spontaneous pneumothorax can lead to adverse outcomes like pneumonia, pleural space infections, and increased readmission rate and hospital length of stay (3,4). Different treatment modalities have been used for treating secondary spontaneous pneumothorax includes pleurodesis with chemical agents or surgical pleurodesis. Pleurodesis is a procedure where the pleural space is obliterated to prevent the recurrence of pneumothorax and pleural effusions by introducing a chemical agent or sclerosant into the pleural space, which causes intense inflammation and fibrosis subsequently leading to adhesions between the two pleural membranes. Different chemical agents available for pleurodesis include doxycycline, tetracycline, minocycline, talc and autologous blood patch (5). Autologous blood patch pleurodesis (ABPP) is a type of pleurodesis in which the patient’s blood is introduced through the intercostal chest drain to achieve pleurodesis. The mechanism behind the closure of the air leak with ABPP is probably due to the patch seal mechanism followed by the inflammatory response (6,7). Over the past years, several alternatives to talc have been studied, and the efficacy of intrapleural tetracycline derivative (doxycycline) has been demonstrated managing pulmonary air leak as well as malignant pleural effusions. However, experience with its use in managing a pneumothorax is limited (8,9). Therefore, this study aims to detect the potential benefit of combining doxycycline with an autologous blood patch depend on its dual mechanisms of action
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2025
Actual trial start date 15/01/2025
Anticipated date of last follow up 15/01/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Autologous blood patch pleurodesis. Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. 45 Active-Treatment of Control Group
Experimental Group autologous blood patch pleurodesis with doxycycline Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, . After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. 45
Control Group Autologous blood patch pleurodesis. Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. 45 Active-Treatment of Control Group
Experimental Group autologous blood patch pleurodesis with doxycycline Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, . After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Adult patients of both sexes Age ≥18 2- Patients with secondary spontaneous pneumothorax and persistent air leak ≥7 days (grade 1-2). Air leak was graded based on Cerfolio classification of air leak 1- Previous history of ipsilateral pleurodesis. 2- Traumatic or primary spontaneous pneumothorax. 3- Patients with underlying haematological disorders- coagulopathies. 4- Known case of allergy to doxycycline 5- Patients with active pulmonary infection 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2025 RB Registration Number U.S. Department of HHS IORG
Ethics Committee Address
Street address City Postal code Country
al imam turki , ulaishah Riyadh 12746 Saudi Arabia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/02/2025 Tanta university research ethics
Ethics Committee Address
Street address City Postal code Country
el bahr street tanta tanta 31111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome A- Primary outcomes Rate of complete cessation of air leak between both groups. Leak until the seventh day of procedure was considered as success until the seventh day of procedure
Secondary Outcome B- Secondary outcomes • Length of hospital stay • Post-procedure complications including fever, tachycardia, emphysema, dyspnea and pain scoring using the numeric pain rating scale until patient discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
king Saud medical city al imam turki ibn abd allah ibn muhammad ulaishah Riyadh 12746 Saudi Arabia
TANTA UNIVERSITY HOSPITAL TANTA aljaysh street tanta 6624033 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed ali mahmoud ahmed ulaishah RIyadh Saudi Arabia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor king Saud medical city ulaishah Riyadh Saudi Arabia Hospital
COLLABORATORS
Name Street address City Postal code Country
ahmed gamal ulaishah riyadh Saudi Arabia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed ali mahmoud ahmed betroa@gmail.com 009660504175309 ulaishah
City Postal code Country Position/Affiliation
riyadh Saudi Arabia associate consultant thoracic surgery
Role Name Email Phone Street address
Scientific Enquiries ahmed gamal elkholy ahmed.elkholy@med.tanta.edu.eg 00201224024023 aljaysh tanta
City Postal code Country Position/Affiliation
tanta Egypt lecture of cardiothoracic surgery Tanta university department
Role Name Email Phone Street address
Public Enquiries AYMAN YOUSEF abusitte@yahoo.com 00966500667132 ulaishah
City Postal code Country Position/Affiliation
riyadh Saudi Arabia consultant thoracic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of individual participant data collected during the trial, after deidentification Informed Consent Form,Study Protocol immediately following publication .no end data anyone can access data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 18/01/2026 more patient included in study 60 90
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 30/04/2025 ticked all applicable age groups Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 06/05/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/04/2025 revise the intervention Control Group, Autologous blood patch pleurodesis., Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/01/2026 more patient included Control Group, Autologous blood patch pleurodesis., Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30, Active-Treatment of Control Group Control Group, Autologous blood patch pleurodesis., Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 45, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/01/2026 more patient included Control Group, Autologous blood patch pleurodesis., Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 45, Active-Treatment of Control Group Control Group, Autologous blood patch pleurodesis., Group 1: Patients who receive one session of 50 ml Autologous blood patch pleurodesis. , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received Autologous blood patch injected into the pleura. A single dose of agent is injected, After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 45, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/04/2025 revise the intervention Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 20 mg /kg doxycycline mixed with 50 ml normal saline solution , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 20 mg /kg doxycycline mixed with 50 ml normal saline solution injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/12/2025 revise the intervention Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 20 mg /kg doxycycline mixed with 50 ml normal saline solution , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 20 mg /kg doxycycline mixed with 50 ml normal saline solution injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30, Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/01/2026 only two group Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/01/2026 more patient included Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 30, Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 45,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/01/2026 more patient included Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, and the pleural drain is closed temporary for 2 hours, and to be unclamped afterwards. After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 45, Experimental Group, autologous blood patch pleurodesis with doxycycline , Patients who will receive one session of 50 ml autologous blood patch pleurodesis and with 200mg doxycycline , all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , All patients in the group received 50 ml autologous blood patch pleurodesis and with 200mg doxycycline injected into the pleura. A single dose of agent is injected, . After pleurodesis, all the patients will be reviewed every 12 h till 7th day of procedure to look for complete cessation of air leak. , 45,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/04/2025 approval from Egypt TRUE, Tanta university research ethics, el bahr street tanta , tanta, 31111, Egypt, , 24 Feb 2025, 0020403332033, dean@med.tanta.edu.eg, 34676_31842_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 30/04/2025 add Name of Source self funded, ulaishah, RIyadh, , Saudi Arabia, Self Funded, Mohamed ali mahmoud ahmed, ulaishah, RIyadh, , Saudi Arabia, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/04/2025 update contact in Egypt Scientific Enquiries, ahmed gamal, elkholy, Dr., ahmed.elkholy@med.tanta.edu.eg, , 00966599627497, ulaishah, riyadh, , Saudi Arabia, associate consultant thoracic surgery Scientific Enquiries, ahmed gamal, elkholy, Dr., ahmed.elkholy@med.tanta.edu.eg, , 00201224024023, aljaysh tanta, tanta, , Egypt, lecture of cardiothoracic surgery Tanta university department