TIME 1 The First Therapeutic Intervention in Malignant Pleural Effusion Trial (TIME1) A 2 x 2 randomised factorial trial to assess whether non-steroidal anti-inflammatory analgesics and small bore chest tubes are less painful than opiate analgesics and large bore chest tubes in pleurodesis for malignant pleural effusion. - TIME 1
- Conditions
- Malignant pleural effusion
- Registration Number
- EUCTR2005-005226-31-GB
- Lead Sponsor
- niversity of Oxford, Nuffield Department of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
Inclusion Criteria:
1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by:
a) Histologically proven pleural malignancy
b) Typical features of pleural malignancy seen on direct vision during thoracoscopy
c) Pleural effusion in the context of histologically proven cancer elsewhere
2. Written informed consent
3. Expected survival more than 1 month
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Age < 18 years
2. Primary lymphoma or small cell lung carcinoma
3. Patients who are pregnant or lactating
4. Inability to give informed consent
5. History of gastrointestinal bleeding or of untreated peptic ulceration
6. Known sensitivity to Non-steroidal anti-inflammatory drugs (NSAIDs) / opiates
7. Hypercapnic respiratory failure
8. Known intravenous drug abuse
9. Severe renal or liver disease
10. Known bleeding diathesis
11. Warfarin therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method