Home » Trials » SLCTR/2017/037
Efficacy of the combination of oral tranexamic acid with oral norethisterone versus oral tranexamic acid alone in treatment of bleeding per vagina during dengue infection - A single blinded,randomized controlled study
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SLCTR Registration Number
SLCTR/2017/037
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Efficacy of the combination of oral tranexamic acid with oral norethisterone versus oral tranexamic acid alone in treatment of bleeding per vagina during dengue infection - A single blinded,randomized controlled study
Public Title of Trial
Tranexamic acid with norethisterone versus tranexamic acid alone in treatment of vaginal bleeding during dengue infection
Disease or Health Condition(s) Studied
Dengue
Scientific Acronym
None
Public Acronym
None
Brief title
Efficacy of the combination of oral tranexamic acid with oral norethisterone versus oral tranexamic acid alone in treatment of bleeding per vagina during dengue infection
Universal Trial Number
U1111-1199-2302
Any other number(s) assigned to the trial and issuing authority
40/17 (ERC: Faculty of Medical Sciences, University of Sri Jayewardenepura.
What is the research question being addressed?
Is the combination of oral tranexamic acid with oral norethisterone more effective than oral tranexamic acid alone in treatment of per vaginal bleeding during dengue infection?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Study setting: The study will be conducted in all female medical wards in National Institute of Infectious Disease, IDH, Angoda.
Method of randomization: After recruiting in to the study all patients will be randomized according to the last digit of the patient’s bed head ticket (BHT) number
Interventions:
Arm 'A' will be given tranexamic acid 1g orally three times a day plus norethisterone 5mg orally three times a day until bleeding completely ceases.
Arm 'B' will be given tranexamic acid 1g orally three times a day plus a matching placebo tablet orally three times a day until bleeding completely ceases.
The assignment information will be kept under lock and key. Neither the patient nor ward staff will be made aware of the randomization at any given point of time. However data collectors, outcome adjudicators, data analysts will not be blinded
The placebo will be manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka.
First dose of medication will be administered within 6 hours of onset of vaginal bleeding.
All other standard management and supportive care will be available equally to both arms based on the Sri Lanka National Guidelines on Management of Dengue Fever and Dengue Haemorrhagic Fever In Adults by the Ministry of Health, Sri Lanka.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Reduction in the quantity of per vaginal bleeding assessed using Pictorial Blood loss Assessment Charts (PBACs) by asking the patient to mark the pattern of soiling (Higham et al, 1990). The soiling will be scored on a 10 point scale. Presence of clots > 1cm will be given a score of 5 points. 100 points in this scoring system will be considered equal to 80ml of blood loss. When the score exceeds this level during the period it will be considered heavy menstrual bleeding. |
[ Daily until cessation of per vaginal bleeding. ] |
|
2.
Reduction in the duration of per vaginal bleeding by 35% or more in those who are treated with the combination of tranexamic acid and norethisterone compared to those who are treated with tranexamic acid alone. The first day of bleeding will be defined as the day in which patient develops vaginal bleeding or starts passing clots. Cessation of bleeding will be considered when the patient free of bleeding for 24 hours. Patient will be re-assessed at 24 hours after bleeding ceases. |
[ Daily until cessation of per vaginal bleeding. ] |
Secondary outcome(s)
|
1.
Requirement of blood transfusions: It will be decided by the treating physician, based on the Sri Lanka National Guidelines on Management of Dengue Fever and Dengue Haemorrhagic Fever In Adults by Ministry of Health. |
[ Daily until recovery: |
|
2.
Duration of illness: The first day of the illness will be defined as the day in which the patient developed fever. The day of recovery will be defined when all of the following 3 criteria are fulfilled: i. Patient afebrile for 24 hours ii. Platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value iii. Return of the haematocrit to the patient's baseline |
[ Daily until recovery ] |
Target number/sample size
100 (50 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-12-01
Anticipated end date
2019-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Science Foundation, Sri Lanka, Grant number: RPHS/2016/D-06
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-07-27
Approval number
40/17
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Ananda Wijewickrama
Visiting Physician
National Institute of Infectious Disease,
IDH,
Angoda, Sri Lanka
Mob: 0777559398
Fax: 0112410031
anandawijewickrama@hotmail.com
Contact Person for Public Queries
Dr. Ananda Wijewickrama
Visiting Physician
National Institute of Infectious Disease,
IDH,
Angoda, Sri Lanka
Mob: 0777559398
Fax: 0112410031
anandawijewickrama@hotmail.com
Primary study sponsor/organization
National Science Foundation
47/5,
Maitland Place,
Colombo 07,
Sri Lanka.
+94 011 2696771
+94 011 2694754
info@nsf.ac.lk
www.nsf.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
