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Completed

NCT Number: NCT06449131

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

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.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, 99191-91778, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Daryoush Hamidi Alamdari, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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