Transfusion of fresh platelets or frozen alternatives in patients with severe thrombocytopenia

Not Applicable

• Conditions: Cancer; Thrombocytopenia (low platelets); Cancer - Leukaemia - Acute leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Myeloma; Blood - Clotting disorders; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Blood - Haematological diseases

• Registration Number: ACTRN12619000322134
• Lead Sponsor: Canberra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal clot firmness on rotational thromboelastometry[Immediately post transfusion]

Secondary Outcome Measures

Name	Time	Method
Clotting time on rotational thromboelastometry[Immediately post transfusion];Platelet deposition area as measured in platelet flow chamber under shear[Immediately post transfusion];Duration of coagulation changes as measured by rotational thromboelastography[Day 1 and Day 2 post transfusion];Clot volume as measured in platelet flow chamber under shear[Immediately post transfusion ]