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ISRCTN
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ISRCTN81226121
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DOI
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10.1186/ISRCTN81226121
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Risk factors for bleeding in haematology patients with low platelet counts
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Scientific title
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Risk factors for haemorrhage in thrombocytopenic haematology patients: a pilot clinical investigation
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Acronym
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aTHenA
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Serial number at source
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N/A
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Study hypothesis
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The primary objective is to identify those abnormalities of the haemostatic system that are clinically significant in patients presenting with an acute haematological malignancy.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Berkshire Research Ethics Committee, 27 May 2010, ref: 10/H0505/47
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Study design
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Observational cohort study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Causes of bleeding in patients with a haematological malignancy associated with severe thrombocytopenia.
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2010
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Anticipated end date
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01/09/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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50
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Interventions
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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 platelet count ≥ 50 x109/L for 3 consecutive days), discharge from hospital or 30 days from the initiation of regular blood sampling.
2. Daily bleeding assessment (same as TOPPs study ISRCTN08758735):
Once platelet count is < 50 x 109/L bleeding assessments will be carried out daily until either platelet count recovery (defined as above), discharge from hospital or once 30 days of daily bleeding assessments have been completed.
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Primary outcome measure(s)
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To characterise abnormalities in the levels of
1. Thromboelastography (ROTEM/TEG)
2. Thrombin generation
3. Platelet function (PFA-100)
4. von Willebrand Factor (vWF)
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Secondary outcome measure(s)
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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)
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Sources of funding
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NHS Blood & Transplant (NHSBT) (UK)
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Trial website
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Publications
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Contact name
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Dr
Lise
Estcourt
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Address
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Level 2
John Radcliffe Hospital
Headley Way
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9BQ
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Country
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United Kingdom
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Email
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lise.estcourt@nhsbt.nhs.uk
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Sponsor
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NHS Blood & Transplant (NHSBT) (UK)
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Address
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c/o Professor Marion Scott
Southmead Road
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City/town
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Bristol
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Zip/Postcode
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BS10 5ND
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Country
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United Kingdom
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Sponsor website:
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http://www.nhsbt.nhs.uk/
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Date applied
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15/06/2010
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Last edited
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07/01/2013
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Date ISRCTN assigned
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20/11/2012
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