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

Phase 2

Completed

• Conditions: Pleural Effusion
• Interventions: Drug: Platelet-Rich Plasma and Fibrin Glue

• Registration Number: NCT06449131
• Lead Sponsor: Daryoush Hamidi Alamdari, PhD

Brief 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.

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 Timeline

• Study Start: 2017-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01
• Study First Submitted: 2024-05-12
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients referred to the cardiac surgery clinic	Platelet-Rich Plasma and Fibrin Glue	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.

Primary Outcome Measures

Name	Time	Method
The rate of air leak that is assessed by Cerfolio classification of the air leak by a single observer	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.
The number of injections until the bubble stops	Through study completion, an average of 40 weeks	PRP-FG (5-7 ml/ kg) was injected into the pleural space through the chest tube.
Patient hospitalization time	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	Through study completion, an average of 40 weeks	The treatment was successful if the bubbling was stopped and lung expansion was done.
Rate of radiolucency	within 48 hours after application of platelet-rich plasma	The percent area on chest x-ray is almost completely transparent to radiation.
Percentage of untreated patients who died	Through study completion, an average of 40 weeks	The bubbling was not stopped, lung expansion was not done and the patient was expired

Trial Locations

Locations (1)

Mashhad University of Medical Sciences; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of