Autologous Blood Patch TherapyABPTNCT04132687
ABPT in Secondary Pneumothorax With Persistent Airleak Study
A study testing autologous blood patch therapy in people with Autologous Blood Patch Therapy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Blood Patch Therapy
- What is being tested?
- autologous blood patch therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesHong Kong
- Study dates
- 10 Sep 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Chun Li Dr Ngai, 852-55699554
Karen Ms Yiu, 35053532 ext. 3532, ysyiu@cuhk.edu.hk
- Active, not recruiting
Prince of Wales Hospital
Hong Kong
About this study
Official title: To Determine the Efficacy of Autologous Blood Patch Therapy in Reducing Air Leak in Secondary Spontaneous Pneumothorax: A Proof-of-Concept Study
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).
Read the 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.
- Conditions
- Autologous Blood Patch Therapy
- Being tested
- autologous blood patch therapy
- Keywords
- digital chest drain device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous blood patch therapyProcedure or surgery
use autologous blood as blood patch therapy in persistent air leak
| Study group | Role | What they receive |
|---|---|---|
| autologous blood patch | Other | autologoust blood patch therapy Receives: Procedure: autologous blood patch therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
air leak reduction
percentage of air leak reduction after autologous blood patch
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start10 Sep 2019
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Blood Patch TherapyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Chun Li, Chinese University of Hong Kong
- Investigators
- Chun Li Dr Ngai, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132687
- Sponsor's protocol ID
- ABPT_protocol_version 3_0
- Acronym
- ABPT
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Efficacy of Autologous Blood Patch Therapy in Reducing Air Leak in Secondary Spontaneous Pneumothorax: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT04132687
- Acronym / sponsor ID
- ABPT / ABPT_protocol_version 3_0
- Conditions
- Autologous Blood Patch Therapy
- Keywords
- digital chest drain device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous blood patch | Other | Procedure: autologous blood patch therapyautologoust blood patch therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous blood patch therapyuse autologous blood as blood patch therapy in persistent air leak | Procedure or surgery | autologous blood patch |
Primary outcome
air leak reduction
Time frame: 48 hours
percentage of air leak reduction after autologous blood patch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Autologous Blood Patch Therapy
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Li Dr Ngai principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous blood patch therapy in people with Autologous Blood Patch Therapy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun Li Dr Ngai, MBchB (852-55699554, jennyngai25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
air leak reduction (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.