Causes of bleeding in patients with a haematological malignancy associated with severe thrombocytopenia. Haematological Disorders Malignant neoplasm of lymphoid, haematopoietic and related tissue, unspecified / Purpura and other haemorrhagic conditions
Conditions
Interventions
1. Blood sampling at enrolment into the study:
Once platelet count is < 50 x109/L blood samples will be taken three times a week until either platelet count recovery (defined as an unsupported platel
Sponsors
NHS Blood & Transplant (NHSBT) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with a haematological malignancy requiring myeloablative chemotherapy or a stem cell transplant 2. Aged 16 years or over 3. Confirmed diagnosis of a haematological malignancy 4. Received, are receiving or are going to receive myelosuppressive chemotherapy on this hospital admission with or without haematopoietic stem cell support (this includes patients undergoing haemopoietic stem cell transplantation -autograft or allograft) 5. Thrombocytopenic or expected to become thrombocytopenic with a platelet count of less than 50 x 10E9/L for at least 5 days 6. Will be treated as an in-patient during their period of thrombocytopenia 7. Able to comply with monitoring
Exclusion criteria
Exclusion criteria: 1. Inherited clotting disorder (e.g. haemophilia) 2. Patients need to remain on regular aspirin (or related drugs), or will require regular doses of anticoagulants (heparin), during the whole period of thrombocytopenia 3. Previously recruited to this study at any stage of their treatment 4. Diagnosed with or with a history of immune thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise abnormalities in the levels of 1. Thromboelastography (ROTEM/TEG) 2. Thrombin generation 3. Platelet function (PFA-100) 4. von Willebrand Factor (vWF) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients who have had a significant haemorrhage defined as a modified WHO grade 2, 3 or 4 haemorrhage. This was chosen as an outcome measure as it encompasses clinically relevant bleeding. 2. Platelet count 3. Haemoglobin (Hb) 4. Mean Platelet Volume (MPV) 5. Immature Platelet Fraction (IPF) | — |
Countries
United Kingdom
Outcome results
None listed