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Published in: Trials 1/2024

Open Access 01-12-2024 | Pleurodesis | Study protocol

ERASURE: early autologous blood pleurodesis for postoperative air leaks—a randomized, controlled trial comparing prophylactic autologous blood pleurodesis versus standard watch and wait treatment for postoperative air leaks following thoracoscopic anatomic lung resections

Authors: Ioannis Karampinis, Christian Ruckes, Fabian Doerr, Servet Bölükbas, Sara Ricciardi, Giuseppe Cardillo, Carlos Galvez, Bogdan Vidmar, Tomaz Stupnik, Vincent Fang, Rene Horsleben Petersen, Eric Dominic Roessner

Published in: Trials | Issue 1/2024

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Abstract

Background

The prolonged air leak is probably the most common complication following lung resections. Around 10–20% of the patients who undergo a lung resection will eventually develop a prolonged air leak. The definition of a prolonged air leak varies between an air leak, which is evident after the fifth, seventh or even tenth postoperative day to every air leak that prolongs the hospital stay. However, the postoperative hospital stay following a thoracoscopic lobectomy can be as short as 2 days, making the above definitions sound outdated. The treatment of these air leaks is also very versatile. One of the broadly accepted treatment options is the autologous blood pleurodesis or “blood patch”. The purpose of this trial is to investigate the impact of a prophylactic autologous blood pleurodesis on reducing the duration of the postoperative air leak and therefore prevent the air leak from becoming prolonged.

Methods

Patients undergoing an elective thoracoscopic anatomic lung resection for primary lung cancer or metastatic disease will be eligible for recruitment. Patients with an air leak of > 100 ml/min within 6 h prior to the morning round on the second postoperative day will be eligible for inclusion in the study and randomization. Patients will be randomized to either blood pleurodesis or watchful waiting. The primary endpoint is the time to drain removal measured in full days. The trial ends on the seventh postoperative day.

Discussion

The early autologous blood pleurodesis could lead to a faster cessation of the air leak and therefore to a faster removal of the drain. A faster removal of the drain would relieve the patient from all the well-known drain-associated complications (longer hospital stay, stronger postoperative pain, risk of drain-associated infection, etc.). From the economical point of view, faster drain removal would reduce the hospital costs as well as the costs associated with the care of a patient with a chest drain in an outpatient setting.

Trial registration

German Clinical Trials Register (DRKS) DRKS00030810. 27 December 2022
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Metadata
Title
ERASURE: early autologous blood pleurodesis for postoperative air leaks—a randomized, controlled trial comparing prophylactic autologous blood pleurodesis versus standard watch and wait treatment for postoperative air leaks following thoracoscopic anatomic lung resections
Authors
Ioannis Karampinis
Christian Ruckes
Fabian Doerr
Servet Bölükbas
Sara Ricciardi
Giuseppe Cardillo
Carlos Galvez
Bogdan Vidmar
Tomaz Stupnik
Vincent Fang
Rene Horsleben Petersen
Eric Dominic Roessner
Publication date
01-12-2024
Publisher
BioMed Central
Keyword
Pleurodesis
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07875-z

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