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Trial registered on ANZCTR
Registration number
ACTRN12611000865910
Ethics application status
Approved
Date submitted
8/08/2011
Date registered
15/08/2011
Date last updated
17/12/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase III Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Tranexamic Acid in Reducing the Blood Loss in Patients with Per-rectal Bleeding
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Scientific title
A Phase III Randomised, Double-blind, Placebo-controlled Pragmatic Trial to Assess the Efficacy of Tranexamic Acid in Reducing the Blood Loss in Patients with Per-rectal Bleeding
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Secondary ID [1]
262741
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Clinical Trial Procotol Number JHHGIS01
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Universal Trial Number (UTN)
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Trial acronym
TRAPR Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
lower gastrointestinal bleeding
270450
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Condition category
Condition code
Oral and Gastrointestinal
270598
270598
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Tranexamic acid 1000mg taken orally every 6 hours for 4 days.
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Intervention code [1]
267088
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Treatment: Drugs
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Comparator / control treatment
Placebo capsule, consisting of rice flour-based capsule, taken orally every 6 hours for four days.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Blood loss as assessed by reduction in haemoglobin concentration.
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Assessment method [1]
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Timepoint [1]
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Day 1, 2, 3, 4 and day of discharge
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Secondary outcome [1]
279407
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Number of units of packed red blood cells administered to participants according to the clinical record
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Assessment method [1]
279407
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Timepoint [1]
279407
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At time of discharge
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Eligibility
Key inclusion criteria
Written informed consent
Per rectum bleeding
Able to swallow study medications
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Subjects less than 18 years
Patients with dementia or other health conditions that prevent a person from giving written informed consent.
History of thromboembolic disease or family history of same.
Subjects taking warfarin.
Subjects that are within 12 months of insertion of a drug-eluting stent.
Subjects that are within 12 weeks of placement of a bare metal stent.
Subjects that are pregnant and/or breastfeeding.
Subjects with a known gastrointestinal malignancy
Subjects with a known cancer in the palliative care phase of their treatment.
Subjects with a known allergy to tranexamic acid or its excipients.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After a potential partiticipant has met all eligibility criteria and written informed consent has been obtained, the researcher will randomise the patient by central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/11/2011
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Actual
9/11/2011
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Date of last participant enrolment
Anticipated
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Actual
7/01/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
1194
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John Hunter Hospital Royal Newcastle Centre - New Lambton
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Recruitment postcode(s) [1]
7056
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2305 - New Lambton Heights
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Funding & Sponsors
Funding source category [1]
267558
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Hospital
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Name [1]
267558
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John Hunter Hospital
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Address [1]
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Lookout Road
New Lambton Heights NSW 2305
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Country [1]
267558
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Australia
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Primary sponsor type
Hospital
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Name
John Hunter Hospital
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Address
Lookout Road
New Lambton Heights NSW 2305
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
266594
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Address [1]
266594
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Country [1]
266594
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269522
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
269522
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Locked Bag 1 New Lambton NSW 2305
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Ethics committee country [1]
269522
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Australia
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Date submitted for ethics approval [1]
269522
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Approval date [1]
269522
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01/08/2011
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Ethics approval number [1]
269522
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11/07/20/3.06
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Summary
Brief summary
A study to assess the effectiveness of oral tranexamic acid to placebo in reducing the amount of blood loss from lower gastrointestinal bleeding, and to reduce the amount of blood needed to be transfused.
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Trial website
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Trial related presentations / publications
DOES TRANEXAMIC ACID REDUCE BLOOD LOSS IN PER RECTAL BLEEDING? (TRAPR STUDY) David Murray, Stephen Smith, Brian Draganic, Peter Pockney, Rosemary Carroll and John Attia ANZ Journal of Surgery Special Issue: Abstracts of the RACS Annual Scientific Congress and ANZCA Annual Scientific Meeting, Singapore, 5–9 May 2014 Volume 84, Issue Supplement S1, pages 30–52, May 2014
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Public notes
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Contacts
Principal investigator
Name
32954
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Dr Stephen Smith
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Address
32954
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Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
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Country
32954
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Australia
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Phone
32954
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+61 2 49855568
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Fax
32954
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Email
32954
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[email protected]
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Contact person for public queries
Name
16201
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Rosemary Carroll
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Address
16201
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Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
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Country
16201
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Australia
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Phone
16201
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+61 2 49855153
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Fax
16201
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+61 2 49214274
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Email
16201
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[email protected]
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Contact person for scientific queries
Name
7129
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Dr Stephen Smith
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Address
7129
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Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
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Country
7129
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Australia
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Phone
7129
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+61 2 49855153
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Fax
7129
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Email
7129
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.
2018
https://dx.doi.org/10.1097/DCR.0000000000000943
N.B. These documents automatically identified may not have been verified by the study sponsor.
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