Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000311550
Ethics application status
Not yet submitted
Date submitted
24/02/2015
Date registered
2/04/2015
Date last updated
2/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effect of Tranexamic Acid (TXA) on the functional fibrinolysis assay in patients with hereditary bleeding disorder (HBD) compared with healthy controls.
Scientific title
Examining the effect of 1g of Tranexamic Acid (TXA) on the functional fibrinolysis assay in patients with hereditary bleeding disorder (HBD) who are having dental or endoscopic procedures compared with healthy controls.
Secondary ID [1] 286246 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary Bleeding Disorder (Haemophilia A and B, Von Willebrand disease) 294301 0
Condition category
Condition code
Blood 294623 294623 0 0
Clotting disorders
Human Genetics and Inherited Disorders 294812 294812 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enrolled patients will ingest one gram of oral tranexamic acid at least 1 hour prior to the procedure (dental or endoscopic) and blood will be collected immediately before and 4 hours post ingestion. Plasma samples will be prepared and stored for evaluation of fibrinolysis utilising contemporary clot lysis assay. Correlation of the results will be made with clinical bleeding as reported by the proceduralist who are blinded to the results.
Tranexamic acid administration will be supervised, only one dose will be given to control and patient group.
Intervention code [1] 291262 0
Treatment: Drugs
Comparator / control treatment
Healthy volunteer subjects will also take a oral dose of one gram of tranexamic acid and have similar plasma samples collected at 2, 4 and 8 hours post ingestion..
They will not be undergoing an invasive procedure.
Control group
Active

Outcomes
Primary outcome [1] 294387 0
We aim to evaluate the impact of TXA on functional fibrionolysis by enrolling patients with hereditary bleeding disorders and healthy controls into the proposed study.

In this study we will examine the rate of clot lysis using the new clot lysis assay. The principle of this turbidometric assay is continuous monitoring of clot formation and lysis by light transmission at 405 nm in a 96 well plate.
Timepoint [1] 294387 0
Baseline and at 4 hours after ingestion of 1 gram of Tranexamic acid for patient group and baseline, 2, 4 and 8 hours for control group.
Secondary outcome [1] 313639 0
NA
Timepoint [1] 313639 0
NA

Eligibility
Key inclusion criteria
One of Hereditary Bleeding Disorder = Haemophilia A, Haemophilia B, or rarer coagulation factor deficiencies {such as factor XI deficiency} and von Willebrand Disease)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breastfeeding
Past history of thrombosis
Past history of renal disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/04/2015
Actual
Date of last participant enrolment
Anticipated
1/01/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3538 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9340 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 290808 0
Charities/Societies/Foundations
Name [1] 290808 0
Australian Haemophilia Centre Directors' Organisation (AHCDO) John Lloyd Clinical Excellence fund

The Fund is a Special Fund under the control and financial management of AHCDO and was created for the purposes of haemophilia research in Australia.
Country [1] 290808 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Commercial rd
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 289495 0
University
Name [1] 289495 0
Monash University
Address [1] 289495 0
Alfred campus
Commercial rd
Prahran VIC 3181
Country [1] 289495 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292434 0
Alfred Hospital Ethics
Ethics committee address [1] 292434 0
Commercial Rd
Prahran VIC 3181
Ethics committee country [1] 292434 0
Australia
Date submitted for ethics approval [1] 292434 0
23/02/2015
Approval date [1] 292434 0
Ethics approval number [1] 292434 0

Summary
Brief summary
It is routine practice at the Haemophilia Treatment Centre at The Alfred that patients who undergo dental extraction or low risk endoscopic procedures receive tranexamic acid (TXA) with or without factor concentrate replacement (depending on proceduralist determined bleeding risk). Despite clinical reports of no increased rate of bleeding utilising this strategy, the underlying biological mechanism has not been extensively explored. We aim to evaluate the impact of TXA on functional fibrionolysis by enrolling such patients and healthy controls into the proposed study.
Enrolled patients will ingest one gram of oral tranexamic acid on the day of procedure and blood will be collected immediately before and 4 hours post ingestion. Plasma samples will be prepared and stored for evaluation of fibrinolysis utilising contemporary clot lysis assay. Correlation of the results will be made with clinical bleeding as reported by the proceduralist who are blinded to the results. Healthy volunteer subjects will also take a dose of one gram of tranexamic acid and have plasma samples collected at 2,4, and 8 hours post ingestion.
Fibrinolysis will be measured using a light transmission based assay where thrombin and tissue plasminogen activator are added to the plasma. The expected effect of tranexamic acid is a delay in fibrinolysis in the control samples. In the patient samples, it is expected that clot formation will be impaired by the bleeding disorder but the tranexamic acid may similarly delay fibrinolysis when compared with controls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55258 0
A/Prof Huyen Tran
Address 55258 0
Head of Haemostasis and Thrombosis Unit
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 55258 0
Australia
Phone 55258 0
+613 9076 2179
Fax 55258 0
Email 55258 0
[email protected]
Contact person for public queries
Name 55259 0
Dr Isaac Goncalves
Address 55259 0
Haematology Unit
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 55259 0
Australia
Phone 55259 0
+613 9076 2000
Fax 55259 0
Email 55259 0
[email protected]
Contact person for scientific queries
Name 55260 0
Prof Robert Metcalf
Address 55260 0
Group Leader, Fibrinolysis and Gene Regulation Laboratory
Level 1, AMREP Bulding
The Alfred, Commercial Road
Prahran Victoria 3181
Country 55260 0
Australia
Phone 55260 0
+61 3 99030133
Fax 55260 0
Email 55260 0
[email protected]

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
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