Inclusion Criteria |
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Patients meeting the following criteria can be included in the trial: |
1. Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell) within the last 6 weeks |
2. Age 18 or over |
3. ECOG Performance status 0, 1, 2 or 3 |
4. Willing and able to self-administer LMWH by daily subcutaneous injection or have it administered to them by a carer |
5. Willing and able to give informed consent. |
Exclusion Criteria |
If any of the following criteria apply, patients cannot be included in the trial: |
1. Patients with other intrathoracic tumours (e.g. carcinoid, mesothelioma, lymphoma, lung metastases from another primary site) |
2. Any previous illness or treatment likely to interfere with protocol treatment or comparisons |
3. Clinically apparent brain metastases |
4. Patients who have had a haemorrhagic stroke in the last 3 months |
5. Haemoptysis of CTC Grade 2 (symptomatic haemoptysis requiring medical intervention) or above |
6. Known bleeding disorder |
7. Known pregnancy or lactation. Effective contraception is essential for all female patients (of reproductive potential) if sexually active |
8. Known hypersensitivity to dalteparin or other low molecular weight heparins and/or heparins (e.g. history of confirmed or suspected immunologically mediated heparin induced thrombocytopenia; acute gastroduodenal ulcer; subacute endocarditis) |
9. Platelet count lower than 100 × 109/L |
10. Renal impairment with serum creatinine greater than 150 μmol/L |
11. Patients who are currently receiving or have received therapeutic anticoagulation in the last 12 months |
12. Patients taking ketorolac (toradol®) - this is a non steroidal anti-inflammatory drug (NSAID) with a well documented risk of causing increased bleeding when given with LMWH |
13. Patients who at the time of randomisation have a central venous catheter in place and the local practice specifies the use of thromboprophylaxis |
14. Any other active malignancy in the last 5 years, except completely treated non-melanoma skin cancer or in-situ carcinoma of cervix. Patients with previous malignancies in remission for at least 5 years can be included, provided that there is a clear MDT decision that this is a new primary. |