PRP in 2ry Spontaneous Pneumothorax

Pneumothorax Spontaneous Secondary Clinical Trial

Official title:

Platelet Rich Plasma in Secondary Spontaneous Pneumothorax

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830645
• Other study ID #: ZU-IRB#4931-4-11-2018
• Status: Recruiting
• Phase: Phase 1
• Start date: November 5, 2018
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Zagazig University
• Contact: Ahmad Abbas, MD
• Phone: 201155355369
• Email: amabbaas[@]zu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion

Exclusion Criteria:

• refusal of participation

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pneumothorax
• Pneumothorax Spontaneous Secondary

Intervention

Biological:
• Platelet Rich Plasma
Application of platelet rich plasma through the intercostal tube into the pleural space

Locations

Country	Name	City	State
Egypt	Zagazig University Faculty of medicine Chest Department	Zagazig	Asharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Air leak assessment by Cerfolio classification of the air leak by single observer	Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation	within 10 days after application of platelet rich plasma
Primary	physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay	no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation	within 10 days after application of platelet rich plasma
Primary	recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung	no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation	one month after removal of intercostal tube
Primary	recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung	no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation	two months after removal of intercostal tube
Primary	recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung	no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation	three months after removal of intercostal tube
Primary	recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung	no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation	six months after removal of intercostal tube