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

NCT06449131 | Completed Phase 2

• 1 other identifier: IR.MUMS.MEDICAL.REC.981289
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Keywords

Pleural Effusion; Persistent; Cardiac surgery; PRP; Fibrin Glue

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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.

Drug: Platelet-Rich Plasma and Fibrin Glue

Interventions

Platelet-Rich Plasma and Fibrin Glue DRUG

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.

patients referred to the cardiac surgery clinic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery
• patients who sign an informed consent form

You may not qualify if:

• Hemodynamically unstable patients
• Patients who did not sign an informed consent form

Sponsors & Collaborators

• Daryoush Hamidi Alamdari, PhD: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, 99191-91778, Iran

Location

MeSH Terms

Conditions

Pleural Effusion

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Daryoush Hamidi-Alamdari, Ph.D

  Mashhad university of medical sience

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: June 7, 2024
• Study Start: May 1, 2017
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)