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Risk factors for bleeding in haematology patients with low platelet counts
DOI 10.1186/ISRCTN81226121
ClinicalTrials.gov identifier
EudraCT number
Public title Risk factors for bleeding in haematology patients with low platelet counts
Scientific title Risk factors for haemorrhage in thrombocytopenic haematology patients: a pilot clinical investigation
Acronym aTHenA
Serial number at source N/A
Study hypothesis The primary objective is to identify those abnormalities of the haemostatic system that are clinically significant in patients presenting with an acute haematological malignancy.
Lay summary Lay summary under review 2
Ethics approval Berkshire Research Ethics Committee, 27 May 2010, ref: 10/H0505/47
Study design Observational cohort study
Countries of recruitment United Kingdom
Disease/condition/study domain Causes of bleeding in patients with a haematological malignancy associated with severe thrombocytopenia.
Participants - 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
Participants - 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
Anticipated start date 01/09/2010
Anticipated end date 01/09/2011
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 50
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 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.
Primary outcome measure(s) 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 outcome measure(s) 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)
Sources of funding NHS Blood & Transplant (NHSBT) (UK)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24797282
Contact name Dr  Lise  Estcourt
  Address Level 2
John Radcliffe Hospital
Headley Way
  City/town Oxford
  Zip/Postcode OX3 9BQ
  Country United Kingdom
  Email lise.estcourt@nhsbt.nhs.uk
Sponsor NHS Blood & Transplant (NHSBT) (UK)
  Address c/o Professor Marion Scott
Southmead Road
  City/town Bristol
  Zip/Postcode BS10 5ND
  Country United Kingdom
  Sponsor website: http://www.nhsbt.nhs.uk/
Date applied 15/06/2010
Last edited 08/05/2014
Date ISRCTN assigned 20/11/2012
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