PRP in 2ry Spontaneous Pneumothorax

NCT03830645 | Unknown Phase 1

• 1 other identifier: ZU-IRB#4931-4-11-2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumothorax Spontaneous Secondary

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Platelet rich plasma group

EXPERIMENTAL

Biological: Platelet Rich Plasma

Interventions

Platelet Rich Plasma BIOLOGICAL

Application of platelet rich plasma through the intercostal tube into the pleural space

Platelet rich plasma group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• refusal of participation

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of medicine Chest Department

Zagazig, Asharqia, 44519, Egypt

RECRUITING

Central Study Contacts

Ahmad Abbas, MD

CONTACT

201155355369; amabbaas@zu.edu.eg

Mohammed Walaa, MD

CONTACT

201002089696

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator &lecturer of chest disases zagazig university

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: February 5, 2019
• Study Start: November 5, 2018
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

EG (1)