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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

16 Oct 2017

The date of last modification

Jan 28, 2019



Application Summary


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.


Trial Details


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

  1. All the patients with an ‘odd number’ as the last digit of BHT number will be labeled as Group A.
  2. All the patients with an ‘even number’ as the last digit of BHT number will be labeled as Group B.

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

  1. Female patients aged over 18 years
  2. Confirmed to have dengue infection (either by dengue NS1 antigen test or by the presence of dengue specific IgM antibodies(rapid strip tests) )
  3. Presence of bleeding per vagina (including menstrual bleeding, inter menstrual bleeding or peri-menopausal bleeding)

Exclusion criteria

  1. Patients who are too ill to give consent
  2. Patients who already have per vaginal bleeding on admission.
  3. Pregnant dengue patients
  4. Patients with per vaginal bleeding due to loss of undetected pregnancy (confirmed by urine hCG strip test)
  5. Past history of thrombo-embolic events including myocardial infarction (MI), transient ischaemic attack (TIA), Cerebro-vascular attack (CVA), pulmonary embolism (PE), deep vein thrombosis (DVT), and disseminated intravascular coagulation (DIC).
  6. History of convulsions.
  7. Women who have reached menopause.
  8. Known clotting disorders.
  9. Anti-coagulant treatment.
  10. History of liver tumors, gynaecological or breast cancers


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:
    The day of recovery will be defined when all of the following 3 criteria are fulfilled: 1. Patient afebrile for 24 hours 2. Platelet counts of >50,000 cells/mm3 or a rise of 20% from the lowest value 3. Return of the haematocrit to the patients baseline

    ]
  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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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