Prolonged Air Leakage After Major Lung Resection

NCT05638113 | Unknown DMC

• 1 other identifier: S-20220068
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective randomized controlled trial is to investigate the clinical effects of autologous blood pleurodesis in the treatment of pulmonary air leaks on the first postoperative day following VATS pulmonary resections. Patients will through web-based randomization be randomly assigned into intrapleural instillation of autologous blood (intervention) or standard treatment with ordinary chest drainage (control).

Conditions

Postoperative Air Leak

Keywords

Blood pleurodesis

Outcome Measures

Primary Outcomes (3)

• Duration of air leakage until sealed.

  Outcome measure will be assessed when the electronic drain box indicates no further air leak. Data will be reported as hours of air leakage until sealed.

  Through study completion, an average of 3 years.

• Duration until chest drain removal.

  Outcome measure will be assessed when the patients chest drain is removed. Data will be reported as hours with chest drain until removed.

  Through study completion, an average of 3 years.

• Duration of hospital stay.

  Outcome measure will be assessed when the patient is discharged from the hospital. Data will be reported as days hospitalized until discharge.

  Through study completion, an average of 3 years.

Study Arms (2)

Blood pleurodesis

ACTIVE COMPARATOR

Procedure: Pleural injection of autologous blood

Simple chest drainage (chest tube)

NO INTERVENTION

Interventions

Pleural injection of autologous blood PROCEDURE

120 ml autologous blood will be drawn from simple venous puncture and immediately injected through the drain into the pleural cavity followed by flushing with 50ml of saline.

Blood pleurodesis

Eligibility Criteria

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

You may qualify if:

• Patients \> 18 years of age
• Patients willing to give informed consent
• Patients undergoing VATS lobectomy
• Patients with a postoperative air leak (\> 20ml/min for at least 6 hours).

You may not qualify if:

• Patients \< 18 years of age
• Patients not willing to give informed consent
• Trauma patients
• Hypotensive patients and patients with a low blood cell count (anemia, thrombocytopenia)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Cardiothoracic Surgery, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Study Officials

• Peter Licht, Professor

  Odense University Hospital

  STUDY DIRECTOR

Central Study Contacts

Finn Dittberner, MD

CONTACT

+45 65411542; finn.orjar.armundsen.dittberner@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Randomized Controlled Trial

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 6, 2022
• Study Start: January 10, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)