A trial looking at using urokinase to help drain fluid from around the lung - TIME3 UK

This trial is looking at using urokinase to help drain more than 1 pocket of fluid from around the lung, to make breathing easier.

Some people with cancer may have fluid collect between the lung and chest wall. This fluid takes up space that your lung would normally expand into when you breathe in. This can make breathing difficult and make you short of breath. This is called pleural effusion.

Doctors can treat this by draining the fluid away. They do this by putting a tube into the space between the chest wall and lung. After draining the fluid, they may also put in talc to stick the lung to the chest wall and stop more fluid collecting. This is called pleurodesis.

But sometimes there is more than 1 pocket of fluid between the lung and chest wall. This makes it difficult to drain all the fluid away.

Urokinase is a drug that may help break down these pockets. This may help doctors drain the fluid from around the lung better.

The aim of this trial is to compare urokinase with a dummy drug (placebo) to see if it

Can help control and improve shortness of breath caused by pleural effusion
Can improve the success rate of pleurodesis

Recruitment

Start 01/09/2009

End 30/06/2014

Phase

Phase 3

Who can enter

You can enter this trial if you

Have more than 1 area of fluid between the lung and chest wall (pleural effusion) that is caused by cancer
Are in hospital with a drain in your chest to drain fluid but the drain is not working
Are at least 18 years old

You cannot enter this trial if you

Have had surgery to remove your lung
Have had major surgery in the past 5 days
Have had an infection of the lining between the lung and chest wall in the last 4 weeks
Are allergic to urokinase
Have had a stroke, an injury or a large amount of bleeding in the past 4 weeks
Have a low number of platelets in your blood or another medical condition that can cause bleeding problems
Have problems with your sight
Are pregnant or breastfeeding

Trial design

This trial will recruit 126 people throughout the UK.

There are 2 groups in this trial. It is a randomised trial. Neither you nor your doctor can choose which group you are in. Half the people will have urokinase. The other half will have the dummy drug (placebo).

Both the urokinase and placebo are fluids. The doctors will put the fluid into the space via the tube you already have in your chest. They will do this every 8 to 14 hours for a total of 3 treatments. They will then allow the fluid to drain away. And between each treatment the tube is open so that any fluid is able to drain away.

After the 3 treatments, you will have talc put in the space between the lung and chest wall to try and stop more fluid collecting there.

For 28 days after this, you will fill in a form to assess your breathing. You do this at home, but someone will go over it with you before you leave hospital. After treatment, you will see the doctor at 1, 3, 6 and 12 months in the outpatients department.

At each appointment you are asked to fill in a questionnaire. It will ask how you are, and about your breathing.