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Trial registered on ANZCTR


Registration number
ACTRN12619000322134
Ethics application status
Approved
Date submitted
23/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Transfusion of fresh platelets or frozen alternatives in patients with severe thrombocytopenia
Scientific title
The effect of cryoprecipitate, cryopreserved platelets and fresh platelet transfusions on measures of haemostasis in patients with thrombocytopenia.
Secondary ID [1] 297511 0
National Blood Authority grant number ID303
Universal Trial Number (UTN)
U1111-1229-1474
Trial acronym
TRiST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 311710 0
Thrombocytopenia (low platelets) 311715 0
Condition category
Condition code
Cancer 310332 310332 0 0
Leukaemia - Acute leukaemia
Cancer 310333 310333 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 310334 310334 0 0
Myeloma
Blood 310335 310335 0 0
Clotting disorders
Cancer 310360 310360 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 310361 310361 0 0
Myeloma
Blood 310362 310362 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313751 0
Treatment: Other
Comparator / control treatment
Transfusion of a single unit of fresh, room temperature stored platelets.
Control group
Active

Outcomes
Primary outcome [1] 319214 0
Maximal clot firmness on rotational thromboelastometry
Timepoint [1] 319214 0
Immediately post transfusion
Secondary outcome [1] 367323 0
Clotting time on rotational thromboelastometry
Timepoint [1] 367323 0
Immediately post transfusion
Secondary outcome [2] 367324 0
Platelet deposition area as measured in platelet flow chamber under shear
Timepoint [2] 367324 0
Immediately post transfusion
Secondary outcome [3] 367325 0
Duration of coagulation changes as measured by rotational thromboelastography
Timepoint [3] 367325 0
Day 1 and Day 2 post transfusion
Secondary outcome [4] 367404 0
Clot volume as measured in platelet flow chamber under shear
Timepoint [4] 367404 0
Immediately post transfusion

Eligibility
Key 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;
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will revert to standard of care after a single transfusion and be observed as controls
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
With a mean pre-transfusion maximum clot firmness of 37mm, a standard deviation of 10mm (for the population) and an expected post treatment MCF of 48mm, 8 patients are needed in each arm comparing pre and post test values, based on a 2 sided paired T test, to demonstrate a difference with 80% power at p<0.05 with transfusion in vivo as was found in vitro.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 13242 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 25800 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 302069 0
Government body
Name [1] 302069 0
National Blood Authority
Address [1] 302069 0
National Blood Authority
Level 2, 243 Northbourne Avenue
Lyneham ACT 2602
Country [1] 302069 0
Australia
Primary sponsor type
Hospital
Name
Canberra Hospital
Address
Yamba Drive
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 301887 0
None
Name [1] 301887 0
None
Address [1] 301887 0
NA
Country [1] 301887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302751 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 302751 0
PO Box 11
WODEN ACT 2606
Ethics committee country [1] 302751 0
Australia
Date submitted for ethics approval [1] 302751 0
05/10/2018
Approval date [1] 302751 0
19/02/2019
Ethics approval number [1] 302751 0
2018.ETH.00188

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91270 0
Dr Philip Crispin
Address 91270 0
Canberra Hospital
Haematology Department
Yamba Drive
Garran ACT 2605
Country 91270 0
Australia
Phone 91270 0
+61262443964
Fax 91270 0
Email 91270 0
philip.crispin@act.gov.au
Contact person for public queries
Name 91271 0
Dr Philip Crispin
Address 91271 0
Canberra Hospital
Haematology Department
Yamba Drive
Garran ACT 2605
Country 91271 0
Australia
Phone 91271 0
+61262443964
Fax 91271 0
Email 91271 0
philip.crispin@act.gov.au
Contact person for scientific queries
Name 91272 0
Dr Philip Crispin
Address 91272 0
Canberra Hospital
Haematology Department
Yamba Drive
Garran ACT 2605
Country 91272 0
Australia
Phone 91272 0
+61262443964
Fax 91272 0
Email 91272 0
philip.crispin@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Trial protocol, individual patient data and analyses
When will data be available (start and end dates)?
Within three months of publication, for at least five years.
Available to whom?
Data deposited in the Australian National University Repository will be open access. De-identified data not placed in the repository will be available to researchers and clinicians by contacting the principle investigator.
Available for what types of analyses?
Any genuine research or clinical request.
How or where can data be obtained?
Through the ANU Data Repository (https://openresearch-repository.anu.edu.au), or contacting the principle investigator.
What supporting documents are/will be available?
No other documents available
Summary results
No Results