None listed
Conditions
Brief summary
The purpose of this study is to evaluate the potential for different blood transfusion strategies to assist with the treatment of thrombocytopenia that has occurred as a result of blood-related cancers, chemotherapy or bone marrow failure. Who is it for? This study is for adults with either a blood related cancer or has been diagnosed with aplastic anaemia and who has low pletelets which would usually be treated with platelet transfusion. Study details Participants will take part in one of two treatment options: 1. The transfusion of cryoprecipitate (a frozen product derived from healthy blood donors), followed by a platelet transfusion, or 2. A frozen platelet transfusion In each case, participants will receive these transfusions in lieu of an expected platelet transfusion, but will be able to continue on with all other therapies. Blood tests will be measured before each transfusion and for up to two days afterwards. Blood tests will be repeated if participants require additional regular platelet transfusions as part of their standard of care. This study is non-randomised. Potential participants will be able to choose a strategy provided that arm remains open. This study will provide information on the effect of these alternative transfusion strategies in this patient group. It is hoped that this may provide a basis for treatment in regions where fresh platelets are not available to treat or reduce the risk of bleeding and enhance our understanding of how this might be best measured.
Interventions
Participants will be offered a single transfusion of cryoprecipitate (20 units), followed by a single unit of platelets or cryopreserved platelets (1 unit).
Haemostasis will be measure before and after each transfusion and daily for up to to days post transfusion. Measurements will be repeated in those participants who progress to standard of care platelet transfusions subsequently.
Participants will be able to select a transfusion strategy (cryoprecipitate or cryopreserved platelets) while e
Participants will be offered a single transfusion of cryoprecipitate (20 units), followed by a single unit of platelets or cryopreserved platelets (1 unit). Haemostasis will be measure before and after each transfusion and daily for up to to days post transfusion. Measurements will be repeated in those participants who progress to standard of care platelet transfusions subsequently. Participants will be able to select a transfusion strategy (cryoprecipitate or cryopreserved platelets) while each arm is open. These are not being primarily compared.
Sponsors
Canberra Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Have a diagnosis of a haematological neoplasm as defined in the WHO Classification of Haematological Neoplasms 2008 or aplastic anaemia; * Be 18 years or older at the date of consent; * Be able to provide informed consent, directly or by means of a facilitator or interpreter for those unable to read or understand English, respectively; * Have a platelet count as measured by routine laboratory full blood of 10x109/L or less; * Have no, or only minor (CTC grade 1 or 2) bleeding; * Have no religious or other objection to blood product transfusion;
Exclusion criteria
* Unable to provide fully informed consent by reason of intellectual, mental or physical disability, or poor understanding of English, except where it can be corrected, such as by the use of a health care interpreter; * Suspected immune thrombocytopenic purpura, thrombotic thrombocytopenic purpura or heparin induced thrombocytopenia; * Acute Promyelocytic leukaemia; * Paroxysmal nocturnal haemoglobinuria; * Established diffuse intravascular coagulation; * Serious active bleeding, defined as grade 3 or above by CTC Criteria; * Where platelet transfusion is expected to be required as prophylaxis for a clinical procedure within 72 hours on enrolment; * Where a treating clinician has prescribed that prophylactic transfusions be given at a platelet count higher than 10x109/L * Antiplatelet therapy within the previous 5 days; * Antithymocyte globulin therapy within the previous 7 days; * Immune mediated refractoriness to platelet transfusion (HLA or HPA mediated); * Prior venous or arterial thrombosis (proven or suspected transient ischaemic attack, stroke or acute coronary syndrome) within three months; * Any prior idiopathic venous thrombosis; * A history of long term anticoagulant therapy at the time of the study, an indication for long term anticoagulation (eg. atrial fibrillation, mechanical prosthetic valve), or where anticoagulation has been ceased or withheld due to thrombocytopenia. * Clinical signs or symptoms suspicious for recent venous thromboembolism, unless investigations excluded this as a cause or an alternative cause has been established.
Outcome results
None listed