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Table 1 Inclusion and exclusion criteria for the FRAGMATIC trial

From: FRAGMATIC: A randomised phase III clinical trial investigating the effect of fragmin® added to standard therapy in patients with lung cancer

Inclusion Criteria
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.