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

Daryoush Hamidi Alamdari, PhD

Status and phase: Completed; Phase 2

Conditions: Pleural Effusion

Treatments: Drug: Platelet-Rich Plasma and Fibrin Glue

Study type: Interventional

Funder types: Other

Identifiers

NCT06449131

IR.MUMS.MEDICAL.REC.981289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

patients referred to the cardiac surgery clinic

Other group

Description:

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.

Treatment:

Drug: Platelet-Rich Plasma and Fibrin Glue