ABPT in Secondary Pneumothorax With Persistent Airleak Study

Autologous Blood Patch Therapy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132687
• Other study ID #: ABPT_protocol_version 3_0
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2019
• Source: Chinese University of Hong Kong
• Contact: Chun Li Dr Ngai, MBchB
• Phone: 852-55699554
• Email: jennyngai25[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 Approximately 1.5ml/kg of venous blood will be withdrawn from the patient and immediately instilled it into the pleural cavity with aseptic technique via the chest tube already in situ.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: October 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Autologous Blood Patch Therapy
• Pneumothorax

Intervention

Procedure:
• autologous blood patch therapy
use autologous blood as blood patch therapy in persistent air leak

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	air leak reduction	percentage of air leak reduction after autologous blood patch	48 hours