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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion
• Intervention / Treatment: Drug: Platelet-Rich Plasma and Fibrin Glue

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Razavi Khorasan
    • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 99191-91778
      • Mashhad University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: patients referred to the cardiac surgery clinic; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Daryoush Hamidi Alamdari, PhD
• Investigators: Study Chair: Daryoush Hamidi-Alamdari, Ph.D, Mashhad university of medical sience

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Persistent; Cardiac surgery; PRP; Pleural Effusion; Fibrin Glue
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: IR.MUMS.MEDICAL.REC.981289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No