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Table 1 Inclusion/exclusion criteria and initial assessment for the ALICAT trial

From: A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective Anticoagulation Length with low molecular weight heparin In the treatment of Cancer Associated Thrombosis (ALICAT): study protocol for a mixed-methods study

Inclusion criteria

1. Receiving LMWH for treatment of CAT for approximately five months

2. Locally advanced or metastatic cancer

3. Able to self-administer LMWH, or have LMWH administered by a carer (routine administration by a district nurse is not permissible)

4. Able to give informed consent

5. Age ≥16 years.

Exclusion criteria

1. Receiving drug other than LMWH for CAT

2. Contraindication to continuing anticoagulation:

a. Known allergies to LMWHs, heparin, sulfites or benzyl alcohol,

b. Active major bleeding,

c. History of heparin-induced thrombocytopenia,

d. Known poor compliance with LMWH,

3. Confirmed recurrent VTE whilst receiving anticoagulation

4. Fitted with a prosthetic heart valve.

Initial assessment

1. Full blood count, urea, electrolytes, liver function, bone profile

2. Physical examination

3. Primary tumor and tumor treatment history

4. Details of LMWH treatment off-trial

5. Baseline concomitant medications

6. Baseline comorbidities (including index VTE and bleeding event history)

7. Use of NHS resources three months prior to commencing trial treatment.

  1. CAT, Cancer associated thrombosis; LMWH, Low molecular weight heparin; NHS, National Health Service; VTE, Venous thromboembolism.