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ABPT in Secondary Pneumothorax With Persistent Airleak Study (ABPT)

Primary Purpose

Autologous Blood Patch Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
autologous blood patch therapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autologous Blood Patch Therapy focused on measuring digital chest drain device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 18 years or older;
  • radiographically proven pneumothorax and underlying lung disease (either pre-existing or shown in diagnostic imaging at presentation);
  • chest tube inserted which still shows an air leak at day 5 (or later) after the first radiographic evidence of a pneumothorax.

Exclusion Criteria:

  • inability to provide informed consent;
  • a chest tube smaller than 12 F (because of the risk of blockage by blood)
  • bilateral pneumothorax
  • uncorrectable coagulopathy
  • active or recent (within 6 weeks) pleural infection
  • use of long term steroid or immunosuppressant
  • septicaemia or active extrapleural infection (eg pneumonia)

Sites / Locations

  • Prince of Wales HospitalRecruiting
  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

autologous blood patch

Arm Description

autologoust blood patch therapy

Outcomes

Primary Outcome Measures

air leak reduction
percentage of air leak reduction after autologous blood patch

Secondary Outcome Measures

Full Information

First Posted
October 17, 2019
Last Updated
October 20, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04132687
Brief Title
ABPT in Secondary Pneumothorax With Persistent Airleak Study
Acronym
ABPT
Official Title
To Determine the Efficacy of Autologous Blood Patch Therapy in Reducing Air Leak in Secondary Spontaneous Pneumothorax: A Proof-of-Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective clinical trial with each patient serving as his/her own control. Patients will be recruited in three different Hong Kong hospital. All patients at the recruitment centers with ongoing air leak after ≥ 3 days from the initial diagnosis of SSP will be approached by site investigators. Patient consented to enter the study will have their rate of air leak measured on day 3 (or after if enrolled later than day 3) byreplacing the conventional chest drain system with the digital chest drainage device (Thopaz). Autologous blood patch will be instilled if the patient still has persistent air leak on day 5 of chest drain insertion ( or 48 hours of electronic chest drain measurement of airleak).
Detailed Description
The patient must have a chest tube in place and checked to be patent. Approximately 1.5ml/kg of venous blood will be withdrawn from the patient and immediately instilled it into the pleural cavity with aseptic technique via the chest tube already in situ. (There is no standard amount of blood used for ABPT. A small randomized study advocated that the use of 1.5ml/kg as it provided the optimal benefits.) The drain is then flushed with 20ml normal saline to avoid clotting. The tube of the drain is immediately elevated to 60cm above the insertion point of the chest tube at the patient's chest wall for 2 hours. This method allows ongoing evacuation of any air leak while the instilled blood can stay within the pleural cavity. The tube is never clamped at any stage to avoid any risk of tension pneumothorax. The patient was asked to change his position in bed every 10 minutes (supine, right lateral, prone, left lateral, head down and sit upright) during the two-hour period to aid distribution of blood over the visceral pleura. The tube is returned to normal position after two hours and the patient is free to ambulate. Analgesia is freely available for the patient should the need arise, but will not be prescribed routinely as existing data suggest it is uncommon. Patients will remain under close observation after the instillation for the next 6 hours by experienced respiratory doctors and nurses, in particular for any suggestion of tube blockage or worsening pneumothorax. The tube will be flushed with saline (of an amount similar to the dead space of the tube) if that occurs. In the very unlikely event that the blockage is not correctable, a new chest tube may be placed if deemed clinically necessary. Prophylactic antibiotics will be given at the discretion of the attending clinician. The amount of air leak is measured continuously before and after ABPT using Thopaz system. Patients are free to receive any other therapy (except pleurodesis) during the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autologous Blood Patch Therapy
Keywords
digital chest drain device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autologous blood patch
Arm Type
Other
Arm Description
autologoust blood patch therapy
Intervention Type
Procedure
Intervention Name(s)
autologous blood patch therapy
Intervention Description
use autologous blood as blood patch therapy in persistent air leak
Primary Outcome Measure Information:
Title
air leak reduction
Description
percentage of air leak reduction after autologous blood patch
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 years or older; radiographically proven pneumothorax and underlying lung disease (either pre-existing or shown in diagnostic imaging at presentation); chest tube inserted which still shows an air leak at day 5 (or later) after the first radiographic evidence of a pneumothorax. Exclusion Criteria: inability to provide informed consent; a chest tube smaller than 12 F (because of the risk of blockage by blood) bilateral pneumothorax uncorrectable coagulopathy active or recent (within 6 weeks) pleural infection use of long term steroid or immunosuppressant septicaemia or active extrapleural infection (eg pneumonia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Li Dr Ngai, MBchB
Phone
852-55699554
Email
jennyngai25@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Li Dr Ngai
Phone
852-55699554
Email
jennyngai25@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Li Dr Ngai
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Li Dr Ngai
Phone
852-55699554
First Name & Middle Initial & Last Name & Degree
Karen Ms Yiu
Phone
35053532
Ext
3532
Email
ysyiu@cuhk.edu.hk
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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ABPT in Secondary Pneumothorax With Persistent Airleak Study

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