Postoperative Air LeakPRALNCT05638113
Prolonged Air Leakage After Major Lung Resection
A study testing Pleural injection of autologous blood in people with Postoperative Air Leak, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The goal of this prospective randomized controlled trial is to investigate the clinical effects of autologous blood pleurodesis in the treatment of pulmonary air leaks on the first postoperative day following VATS pulmonary resections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Air Leak
- What is being tested?
- Pleural injection of autologous blood
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2023to 31 Oct 2025
- 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
- Patients > 18 years of age
- Patients willing to give informed consent
- Patients undergoing VATS lobectomy
- Patients with a postoperative air leak (> 20ml/min for at least 6 hours).
Who cannot join
- Patients < 18 years of age
- Patients not willing to give informed consent
- Trauma patients
- Hypotensive patients and patients with a low blood cell count (anemia, thrombocytopenia)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiothoracic Surgery, Odense University Hospital
Odense, Region Syddanmark, 5000
Finn Dittberner, MD, +45 65411542, finn.orjar.armundsen.dittberner@rsyd.dk
About this study
The goal of this prospective randomized controlled trial is to investigate the clinical effects of autologous blood pleurodesis in the treatment of pulmonary air leaks on the first postoperative day following VATS pulmonary resections. Patients will through web-based randomization be randomly assigned into intrapleural instillation of autologous blood (intervention) or standard treatment with ordinary chest drainage (control).
Read the detailed description
The investigators will conduct a randomized controlled trial enrolling patients undergoing elective VATS-lobectomy. Patients will be randomly assigned into two groups through web-based randomization. Air leak will be measured intraoperatively by submersion tests and postoperatively using standard electronic chest tube devices (Thopaz) with a regulated pressure of -10 cmH2O. If an air leak is present on the 1st postoperative day (20 ml/min or greater for at least 6 hours) patients will be invited to participate in this study.
Following informed consent, the patient is randomized on a web-based randomization module to receive intervention or observation. The intervention group will receive intrapleural instillation of autologous blood in accordance with the standard blood patch protocol at Odense University Hospital. In short, 120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline. No anticoagulation or coagulating agents will be added. All other aspects of the patient's postoperative management will be according to the department's standard protocols.
Standard preoperative information on smoking status, medications, medical history of lung diseases, BMI, spirometry as well as DLCO measurements will be recorded. Detailed information about the surgical treatment will also be recorded (site of anatomical resection, adherences, standard perioperative assessment of air leakage, and type of mechanical linear staplers).
All chest drains will be connected to a standard electronic chest tube device (Thopaz) for continuous recording of air leakage and the drain is removed during daytime or evening shifts when air leakage has ceased to 20 ml/min or less for at least 6 hours according to the standard postoperative management. In addition, all included patients will undergo standard postoperative observations, including recording of vital signs (blood pressure, heart rate, fever, saturation-%) and standard blood samples (CRP and leukocyte count) on postoperative day 2 and subsequent daily if there is a suspicion of infection, pleural effusions, empyema and drain-site infections. Pain will be assessed twice daily using a standardized 0-10 visual analog scale (VAS) where 0 represents no pain and 10 the worst imaginable pain.
Electronic recordings of air leakage from the electronic chest tube device will be analyzed from drain placement in the operating room, until drain removal. If air leakage is still present on postoperative day 7, treatment is considered a failure and further management will be individualized by the responsible surgeon including the need for re-operation in accordance with the department's standard of care.
In the control group everything listed above will apply in the same manner except the intrapleural instillation of autologous blood.
- Conditions
- Postoperative Air Leak
- Being tested
- Pleural injection of autologous blood
- Keywords
- Blood pleurodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural injection of autologous bloodProcedure or surgery
120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline.
| Study group | Role | What they receive |
|---|---|---|
| Blood pleurodesis | Active comparator | Not described Receives: Procedure: Pleural injection of autologous blood |
| Simple chest drainage (chest tube) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of air leakage until sealed.
Outcome measure will be assessed when the electronic drain box indicates no further air leak. Data will be reported as hours of air leakage until sealed.
Measured: Through study completion, an average of 3 years.
Duration until chest drain removal.
Outcome measure will be assessed when the patients chest drain is removed. Data will be reported as hours with chest drain until removed.
Measured: Through study completion, an average of 3 years.
Duration of hospital stay.
Outcome measure will be assessed when the patient is discharged from the hospital. Data will be reported as days hospitalized until discharge.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start10 Jan 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Air LeakStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Ørjar Amundsen Dittberner, Odense University Hospital
- Investigators
- Peter Licht, Professor, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638113
- Sponsor's protocol ID
- S-20220068
- Acronym
- PRAL
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Air Leakage After Major Lung Resection
- ClinicalTrials.gov ID
- NCT05638113
- Acronym / sponsor ID
- PRAL / S-20220068
- Conditions
- Postoperative Air Leak
- Keywords
- Blood pleurodesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 6 Dec 2022 (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.
The goal of this prospective randomized controlled trial is to investigate the clinical effects of autologous blood pleurodesis in the treatment of pulmonary air leaks on the first postoperative day following VATS pulmonary resections. Patients will through web-based randomization be randomly assigned into intrapleural instillation of autologous blood (intervention) or standard treatment with ordinary chest drainage (control).
Detailed description
The investigators will conduct a randomized controlled trial enrolling patients undergoing elective VATS-lobectomy. Patients will be randomly assigned into two groups through web-based randomization. Air leak will be measured intraoperatively by submersion tests and postoperatively using standard electronic chest tube devices (Thopaz) with a regulated pressure of -10 cmH2O. If an air leak is present on the 1st postoperative day (20 ml/min or greater for at least 6 hours) patients will be invited to participate in this study.
Following informed consent, the patient is randomized on a web-based randomization module to receive intervention or observation. The intervention group will receive intrapleural instillation of autologous blood in accordance with the standard blood patch protocol at Odense University Hospital. In short, 120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline. No anticoagulation or coagulating agents will be added. All other aspects of the patient's postoperative management will be according to the department's standard protocols.
Standard preoperative information on smoking status, medications, medical history of lung diseases, BMI, spirometry as well as DLCO measurements will be recorded. Detailed information about the surgical treatment will also be recorded (site of anatomical resection, adherences, standard perioperative assessment of air leakage, and type of mechanical linear staplers).
All chest drains will be connected to a standard electronic chest tube device (Thopaz) for continuous recording of air leakage and the drain is removed during daytime or evening shifts when air leakage has ceased to 20 ml/min or less for at least 6 hours according to the standard postoperative management. In addition, all included patients will undergo standard postoperative observations, including recording of vital signs (blood pressure, heart rate, fever, saturation-%) and standard blood samples (CRP and leukocyte count) on postoperative day 2 and subsequent daily if there is a suspicion of infection, pleural effusions, empyema and drain-site infections. Pain will be assessed twice daily using a standardized 0-10 visual analog scale (VAS) where 0 represents no pain and 10 the worst imaginable pain.
Electronic recordings of air leakage from the electronic chest tube device will be analyzed from drain placement in the operating room, until drain removal. If air leakage is still present on postoperative day 7, treatment is considered a failure and further management will be individualized by the responsible surgeon including the need for re-operation in accordance with the department's standard of care.
In the control group everything listed above will apply in the same manner except the intrapleural instillation of autologous blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Blood pleurodesis | Active comparator | Procedure: Pleural injection of autologous blood |
| Simple chest drainage (chest tube) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18 years of age
- Patients willing to give informed consent
- Patients undergoing VATS lobectomy
- Patients with a postoperative air leak (> 20ml/min for at least 6 hours).
Key exclusion criteria (4 listed)
- Patients < 18 years of age
- Patients not willing to give informed consent
- Trauma patients
- Hypotensive patients and patients with a low blood cell count (anemia, thrombocytopenia)
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 |
|---|---|---|
| Pleural injection of autologous blood120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline. | Procedure or surgery | Blood pleurodesis |
Primary outcome
Duration of air leakage until sealed.
Time frame: Through study completion, an average of 3 years.
Outcome measure will be assessed when the electronic drain box indicates no further air leak. Data will be reported as hours of air leakage until sealed.
Duration until chest drain removal.
Time frame: Through study completion, an average of 3 years.
Outcome measure will be assessed when the patients chest drain is removed. Data will be reported as hours with chest drain until removed.
Duration of hospital stay.
Time frame: Through study completion, an average of 3 years.
Outcome measure will be assessed when the patient is discharged from the hospital. Data will be reported as days hospitalized until discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Peter Licht, Professor study director
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural injection of autologous blood in people with Postoperative Air Leak, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 4 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 Finn Dittberner, MD (+45 65411542, finn.orjar.armundsen.dittberner@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of air leakage until sealed. (time frame: Through study completion, an average of 3 years.). The study lists 3 primary outcomes in all. 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 Mar 2023.