Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000597291
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
20/07/2009
Date last updated
8/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study evaluating the effect of platelet transfusion using an electromechanical infusion pump versus conventional gravity flow method
Scientific title
A pilot study evaluating the effect of platelet
transfusion method administered via an electromechanical infusion pump versus conventional gravity flow method on quality and quantity of transfused platelets
Secondary ID [1] 288711 0
nil known
Universal Trial Number (UTN)
Trial acronym
PLATTRANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platelet transfusion 236921 0
Condition category
Condition code
Blood 237279 237279 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our current practice at the Launceston General Hospital (LGH) and many other medical centres in Australia is to administer platelets via a free flowing gravity line. However there are a few reports that employ a pump during platelet-administration as an acceptable practice. Administration of platelets via a pump would ensure the platelets are infused in a timely fashion but in the meantime, we should ensure that the pumping action will not damage the platelets. There are 4 methods for platelets transfusion including 3 pumps currently available on the oncology ward at the LGH and used for red cell transfusion; 1. The Graseby 3000 2. the Imed Gemini PC-1 and PC-2 (double pump) and 3. Baxter Pump. Furthermore the pump offers well controlled infusion rate, accurate volume measurement and an alarm system for monitoring infusion.

1. gravity flow method - platelets transfused over approximately 30 minutes; 2. Transfusion using the Graseby 3000 takes approximately 15-20 minutes; 3. Transfusion using the Imed Gemini PC-1 and PC-2 (double pump) takes approximately 20 minutes.
4.Transfusion using the baxter pump takes approximately 20 minutes
There is very little data, if any, comparing the effect of the above two recognised methods on platelet-increment after transfusion.
This pilot study is aiming to determine whether infusion method influences the quality and quantity of platelets transfused. Also to determine the most efficient procedure for the administration of platelets either via electromechanical pump or through gravity method. The study will take place until end of Dec 2009.
Intervention code [1] 236710 0
Other interventions
Intervention code [2] 236924 0
Treatment: Devices
Comparator / control treatment
Although both methods for platelets transfusion utilising both either electromechanical pump or through free flowing gravity are well recognised and considered as standard treatment, there is little data available regarding a comparison of the two methods, which their applications vary according the treatment centre in Australia and the rest of the world.
Control group
Active

Outcomes
Primary outcome [1] 238092 0
The aim of this pilot study is to evaluate whether infusion method influences the quality and quantity of platelets transfused.
Platelets count and function will be assessed after transfusion via full blood count and flow cytometry techniques.
Timepoint [1] 238092 0
Main outcome will be measured by platelet count prior to transfusion and platelet count increment after 60 min of completion of transfusion as well as 24 hours post platelet transfusion recovery as per current
standard practice.
Secondary outcome [1] 242293 0
To determine the most efficient procedure for the administration of platelets.
Also whether the rate and method of transfusion influences the quality and quantity of platelets transfused. Platelets count and function will be assessed after transfusion via full blood count and flow cytometry techniques.
Timepoint [1] 242293 0
Until the end of study Dec 2009
Secondary outcome [2] 244812 0
Other factors that might influence platelet recovery include presence of infection/ Dissiminated intravascular coagulopathy (DIC), drugs administration and occurrence of transfusion reactions. These will be studied and recorded as per protocol for correlation with platelet recovery.
Studying the effect of the rate of transfusion via a pump will also be examined and recorded.
Timepoint [2] 244812 0
Until the end of study Dec 2009

Eligibility
Key inclusion criteria
Patients requiring a platelet infusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with severe infection/ sepsis with temperature>38.5 C.
2. Patients with coagulopathy / DIC
3. Patients with platelet refractoriness e.g. platelet antibody or human leucocyte antigen (HLA) antibody.
4. Patients under the age of 18 years.
5. Patients with an intellectual or mental impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We anticipate that almost 120 participants could be enrolled in our trial per year; 30-40 in each arm. Patients will be randomised 1:1:1 into three groups with an equal male to female ratio as possible. Group 1: gravity flow, Group 2: electromechanical pump used at LGH for platelts transfusion and Group 3: other electromechanical pump that used at LGH for platelts transfusion.
Allocation was randomly concealed with random numbered containers at the central administration site.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
31/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 237098 0
Charities/Societies/Foundations
Name [1] 237098 0
Clifford Craig Medical Trust Foundation
Country [1] 237098 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Trust Foundation
Address
PO Box 1963
Launceston
Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 4602 0
Hospital
Name [1] 4602 0
Launceston General Hospital
Address [1] 4602 0
Charles Street, Launceston
Tasmania, 7250
Country [1] 4602 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239197 0
Tasmania Health and Medical Human Research Ethics Committee EC00337
Ethics committee address [1] 239197 0
Executive Officer
University of Tasmania (UTAS) Research and Development Office
GPO Box 252-01
Hobart
Tasmania 7001
Ethics committee country [1] 239197 0
Australia
Date submitted for ethics approval [1] 239197 0
Approval date [1] 239197 0
03/03/2008
Ethics approval number [1] 239197 0
H0009779

Summary
Brief summary
Our current practice at the Launceston General Hospital (LGH) and many centres in Australia is to administer platelets via a free flowing gravity line. However there are a few reports that employ a pump during platelet-administration as an acceptable practice. Administration of platelets via a pump would ensure the platelets are infused in a timely fashion but in the meantime, we should ensure that the pumping action will not damage the platelets. There are 2 pumps currently available on the oncology ward at the LGH and used for red cell transfusion; the Graseby 3000 and the Imed Gemini PC-1 and PC-2 (double pump). Furthermore the pump offers wellcontrolled infusion rate, accurate volume measurement and an alarm system for monitoring infusion.
There is very little data, if any, comparing the effect of the above two recognised methods on platelet-increment after transfusion.
This pilot study is aiming to determine whether infusion method influences the quality and quantity of platelets transfused. Also to determine the most efficient procedure for the administration of platelets.
Trial website
Trial related presentations / publications
Alhossain A. Khalafallah, Abdul Majeed Al-Barzan, Annette Camino, Iain K. Robertson, Gerald Bates Dawn Richardson, Catherine Austen, David Seaton, Wolfgang Heller and Terry Brain. An Open-Labelled, Randomized Cross-Over Study of the Effect of Electromechanical Pumps versus Conventional Gravity Flow on Platelet Transfusion in Adult Haematology Patients. Transfus Med Hemother 2013;40:22–26. DOI: 10.1159/000345681.

http://www.karger.com/Article/Pdf/345681
http://scholar.google.com.au/citations?view_op=view_citation&hl=en&user=7Ntik6EAAAAJ&cstart=20&citation_for_view=7Ntik6EAAAAJ:Se3iqnhoufwC
Public notes

Contacts
Principal investigator
Name 29699 0
Prof Alhossain A. Khalafallah
Address 29699 0
Launceston General Hospital,
Charles Street, Launceston, TAS 7250
Country 29699 0
Australia
Phone 29699 0
+61367776777
Fax 29699 0
Email 29699 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 12946 0
Prof Assoc Prof Alhossain Khalafallah
Address 12946 0
Launceston General Hospital
Charles St
Launceston
Tasmania 7250
Country 12946 0
Australia
Phone 12946 0
+613 6348 7111
Fax 12946 0
Email 12946 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 3874 0
Prof Assoc Prof Alhossain Khalafallah
Address 3874 0
Launceston General Hospital
Charles St
Launceston
Tasmania 7250
Country 3874 0
Australia
Phone 3874 0
+613 6348 7111
Fax 3874 0
Email 3874 0
khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn open-labelled, randomized cross-over study of the effect of electromechanical pumps versus conventional gravity flow on platelet transfusion in adult haematology patients.2013https://dx.doi.org/10.1159/000345681
N.B. These documents automatically identified may not have been verified by the study sponsor.