Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue

Pleural Effusion Clinical Trial

Official title:

Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue: A Clinical Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06449131
• Other study ID #: IR.MUMS.MEDICAL.REC.981289
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2017
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2024
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery

• patients who sign an informed consent form

Exclusion Criteria:

• Hemodynamically unstable patients

• Patients who did not sign an informed consent form

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Drug:
• Platelet-Rich Plasma and Fibrin Glue
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Medical Sciences	Mashhad	Razavi Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Daryoush Hamidi Alamdari, PhD

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 48 hours after application of platelet-rich plasma
Primary	Rate of radiolucency	The percent area on chest x-ray is almost completely transparent to radiation.	within 48 hours after application of platelet-rich plasma
Primary	Patient hospitalization time	Duration of the patient's stay in hospital, assessed up to 40 weeks	From the time the patient is admitted to the hospital to the time of discharge
Primary	Percentage of patients completely recovered	The treatment was successful if the bubbling was stopped and lung expansion was done.	Through study completion, an average of 40 weeks
Primary	Percentage of untreated patients who died	The bubbling was not stopped, lung expansion was not done and the patient was expired	Through study completion, an average of 40 weeks
Primary	The number of injections until the bubble stops	PRP-FG (5-7 ml/ kg) was injected into the pleural space through the chest tube.	Through study completion, an average of 40 weeks