Pleural EffusionPhase 2NCT06449131
Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue
A Phase 2 study testing Platelet-Rich Plasma and Fibrin Glue in people with Pleural Effusion, run by Daryoush Hamidi Alamdari, PhD at 1 site in Iran.
Trial summary
Persistent pleural effusion is a life-threatening complication after cardiac surgery. The traditional treatment is chest tube drainage, which may not respond to treatment. This study introduces a new noninvasive approach for treating persistent pleural effusion using platelet-rich plasma fibrin glue (PRP-FG). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Platelet-Rich Plasma and Fibrin Glue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIran
- Study dates
- 1 May 2017to 1 May 2024
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery
- patients who sign an informed consent form
Who cannot join
- Hemodynamically unstable patients
- Patients who did not sign an informed consent form
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 99191-91778
About this study
Official title: Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue: A Clinical Trail
Persistent pleural effusion is a life-threatening complication after cardiac surgery. The traditional treatment is chest tube drainage, which may not respond to treatment. This study introduces a new noninvasive approach for treating persistent pleural effusion using platelet-rich plasma fibrin glue (PRP-FG). This method has been successfully applied for the treatment of postoperative persistent chylothorax and pneumothorax in previous studies, which significantly decreased morbidity, mortality, and hospital stay.
Read the detailed description
This pilot clinical trial recruited 19 patients at Imam Reza Hospital in Mashhad, Iran (2023) who had developed unilateral or bilateral refractory postoperative effusion resistant to conventional thoracostomy treatment. Treatment success was defined as effusion <50 ml/day after 48 hours, along with symptomatic improvement and no adverse events.
- Conditions
- Pleural Effusion
- Being tested
- Platelet-Rich Plasma and Fibrin Glue
- Keywords
- Pleural Effusion, Persistent, Cardiac surgery, PRP, Fibrin Glue
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma and Fibrin GlueDrug
Allogenic platelet-rich plasma with fibrin glue (PRP-FG) was derived from blood obtained from a blood bank. Peripheral blood (400 ml) was collected from a donor with a matching ABO blood type, and rigorous viral safety tests were conducted. Concentrated PRP (10 ml) was obtained by subjecting the sample to centrifugation at 4000 g for 15 min to separate the plasma from the sedimented platelets.
Fibrinogen was extracted from the separated plasma using cryoprecipitation. After freezing at -70°C followed by thawing at 4°C, fibrinogen concentrate (20 ml) was prepared by centrifugation at 6500 × g for 5 min. The concentrated PRP was combined with fibrinogen (30 ml).
Thrombin was generated from the plasma isolated during the second centrifugation step. The ionic strength and pH were adjusted to precipitate prothrombin. The resulting precipitate was separated by centrifugation and dissolved in a calcium ion solution, resulting in a final volume of 5 ml of thrombin solution.
| Study group | Role | What they receive |
|---|---|---|
| patients referred to the cardiac surgery clinic | Other | This clinical trial focused on patients referred to the cardiac surgery clinic of Imam Reza Hospital in Mashhad 2023 who were diagnosed with unilateral or bilateral pleural effusion resistant to conservative management. Receives: Drug: Platelet-Rich Plasma and Fibrin Glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of air leak that is assessed by Cerfolio classification of the air leak by a 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.
Measured: within 48 hours after application of platelet-rich plasma
Rate of radiolucency
The percent area on chest x-ray is almost completely transparent to radiation.
Measured: within 48 hours after application of platelet-rich plasma
Patient hospitalization time
Duration of the patient's stay in hospital, assessed up to 40 weeks
Measured: From the time the patient is admitted to the hospital to the time of discharge
Percentage of patients completely recovered
The treatment was successful if the bubbling was stopped and lung expansion was done.
Measured: Through study completion, an average of 40 weeks
Percentage of untreated patients who died
The bubbling was not stopped, lung expansion was not done and the patient was expired
Measured: Through study completion, an average of 40 weeks
The number of injections until the bubble stops
PRP-FG (5-7 ml/ kg) was injected into the pleural space through the chest tube.
Measured: Through study completion, an average of 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 May 2017
- Primary completion1 May 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daryoush Hamidi Alamdari, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daryoush Hamidi Alamdari, PhD, Mashhad University of Medical Sciences
- Investigators
- Daryoush Hamidi-Alamdari, Ph.D, Study chair, Mashhad university of medical sience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449131
- Sponsor's protocol ID
- IR.MUMS.MEDICAL.REC.981289
- Status last verified
- Jun 2024
- First submitted
- 12 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue: A Clinical Trail
- ClinicalTrials.gov ID
- NCT06449131
- Acronym / sponsor ID
- IR.MUMS.MEDICAL.REC.981289
- Conditions
- Pleural Effusion
- Keywords
- Pleural Effusion, Persistent, Cardiac surgery, PRP, Fibrin Glue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Daryoush Hamidi Alamdari, PhDUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Jun 2024 (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.
Persistent pleural effusion is a life-threatening complication after cardiac surgery. The traditional treatment is chest tube drainage, which may not respond to treatment. This study introduces a new noninvasive approach for treating persistent pleural effusion using platelet-rich plasma fibrin glue (PRP-FG). This method has been successfully applied for the treatment of postoperative persistent chylothorax and pneumothorax in previous studies, which significantly decreased morbidity, mortality, and hospital stay.
Detailed description
This pilot clinical trial recruited 19 patients at Imam Reza Hospital in Mashhad, Iran (2023) who had developed unilateral or bilateral refractory postoperative effusion resistant to conventional thoracostomy treatment. Treatment success was defined as effusion <50 ml/day after 48 hours, along with symptomatic improvement and no adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients referred to the cardiac surgery clinic | Other | Drug: Platelet-Rich Plasma and Fibrin GlueThis clinical trial focused on patients referred to the cardiac surgery clinic of Imam Reza Hospital in Mashhad 2023 who were diagnosed with unilateral or bilateral pleural effusion resistant to conservative management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery
- patients who sign an informed consent form
Key exclusion criteria (2 listed)
- Hemodynamically unstable patients
- Patients who did not sign an informed consent form
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 |
|---|---|---|
| Platelet-Rich Plasma and Fibrin GlueAllogenic platelet-rich plasma with fibrin glue (PRP-FG) was derived from blood obtained from a blood bank. Peripheral blood (400 ml) was collected from a donor with a matching ABO blood type, and rigorous viral safety tests were conducted. Concentrated PRP (10 ml) was obtained by subjecting the sample to centrifugation at 4000 g for 15 min to separate the plasma from the sedimented platelets. Fibrinogen was extracted from the separated plasma using cryoprecipitation. After freezing at -70°C followed by thawing at 4°C, fibrinogen concentrate (20 ml) was prepared by centrifugation at 6500 × g for 5 min. The concentrated PRP was combined with fibrinogen (30 ml). Thrombin was generated from the plasma isolated during the second centrifugation step. The ionic strength and pH were adjusted to precipitate prothrombin. The resulting precipitate was separated by centrifugation and dissolved in a calcium ion solution, resulting in a final volume of 5 ml of thrombin solution. | Drug | patients referred to the cardiac surgery clinic |
Primary outcome
The rate of air leak that is assessed by Cerfolio classification of the air leak by a single observer
Time frame: within 48 hours after application of platelet-rich plasma
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.
Rate of radiolucency
Time frame: within 48 hours after application of platelet-rich plasma
The percent area on chest x-ray is almost completely transparent to radiation.
Patient hospitalization time
Time frame: From the time the patient is admitted to the hospital to the time of discharge
Duration of the patient's stay in hospital, assessed up to 40 weeks
Percentage of patients completely recovered
Time frame: Through study completion, an average of 40 weeks
The treatment was successful if the bubbling was stopped and lung expansion was done.
Percentage of untreated patients who died
Time frame: Through study completion, an average of 40 weeks
The bubbling was not stopped, lung expansion was not done and the patient was expired
The number of injections until the bubble stops
Time frame: Through study completion, an average of 40 weeks
PRP-FG (5-7 ml/ kg) was injected into the pleural space through the chest tube.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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.
Daryoush Hamidi-Alamdari, Ph.D study chair
Mashhad university of medical sience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet-Rich Plasma and Fibrin Glue in people with Pleural Effusion, run by Daryoush Hamidi Alamdari, PhD at 1 site in Iran.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jun 2024. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of air leak that is assessed by Cerfolio classification of the air leak by a single observer (time frame: within 48 hours after application of platelet-rich plasma). The study lists 6 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 7 Jun 2024.