Pleurodesis with autologous blood may result in shorter length of stay of inpatients who have a chest tube. This study is designed to evaluate its significance in pneumothorax patients.
ID
Source
Brief title
Condition
- Pleural disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Shorten length of stay
Secondary outcome
duration of air leak
duration of drainage
complications
fever till 72 hours after pleurodesis
fever after 72 hours after pleurodesis
empyema
positive culture of pleural fluid
need to surgical intervention due to persistance of air lek (VATS, thoracotomy)
recurrence rate within one month and after one year
Background summary
Pneumothorax is relatively common, most of the patients should have a chest
tube for a period of at least a few days. Pleurodesis with autologous blood may
shorten the length of stay. There are a few non-randomised, relatively small
studies confirming this hypothesis as it was proven to be a highly effective
and safe procedure.
Study objective
Pleurodesis with autologous blood may result in shorter length of stay of
inpatients who have a chest tube. This study is designed to evaluate its
significance in pneumothorax patients.
Study design
After insertion of a chest tube the patients are observed for air leak. If
there are air leak after 24 - 36 hours the patient may be included if he is
eligible and signs the informed consent. The patients are randomised and
included in two groups, one study group and one control group. The patients in
study group would have pleurodesis with 100 ml autologous blood. Thereafter is
management of the patient in both groups are the same and contains the standard
pneumothorax management with chest tube.
Intervention
After insertion of chest tube:
- Patients in the study group: if after 24 - 36 hours still air leak,
pleurodesis with 100 ml autologous blood.
- Control group: observation only
Study burden and risks
Pleurodesis with autologous blood is painless and without other discomfort.
Blood taken from a vein is not associated with much discomfort. The procedure
is very safe and the incidence of adverse events is reported to be very low.
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
eligible for the study, need to have tube insertion, air leak > 24 hours after thorax drian is inserted
Exclusion criteria
post-operative pneumothorax, signs of bacteremia, pneumothorax as a result of multitrauma, recurrent pneumothorax
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15660.094.07 |