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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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.
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, Iran
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Through study completion, an average of 40 weeks
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