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Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial

Primary Purpose

Cerebral Hemorrhage

Status
Recruiting
Phase
Early Phase 1
Locations
Nepal
Study Type
Interventional
Intervention
Tranexamic Acid 500 MG
Sponsored by
Kathmandu Medical College and Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Hemorrhage focused on measuring double blind randomized trial, spontaneous intracerebral hemorrhage, tranexamic acid

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients presenting to the emergency department with symptom of hemorrhagic stroke within 24 hours from onset of symptom or last seen well.
  2. Patient who had a follow up

Exclusion Criteria:

  1. Glasgow coma scale <9 after resuscitation (as this can lead to biasness; requires surgery)
  2. Contraindication to tranexamic acid,
  3. Hemorrhagic stroke secondary to trauma,
  4. Hemorrhage was caused by coagulopathy

Sites / Locations

  • KMC Teaching Hospital, Kathmandu, NepalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

tranexamic acid

Sodium Chloride

Arm Description

Four 5ml solution of either tranexamic acid 500mg or sodium chloride 0.9% are distributed which cannot be differentiated from the appearance. Loading dose of trial (1g of tranexamic acid in 10ml) or placebo (10 ml of sodium chloride 0.9%) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial or placebo mixed in 500ml sodium chloride 0.9% is given over 8 hours

Four 5ml solution of either tranexamic acid 500mg or sodium chloride 0.9% are distributed which cannot be differentiated from the appearance. Loading dose of trial (1g of tranexamic acid in 10ml) or placebo (10 ml of sodium chloride 0.9%) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial or placebo mixed in 500ml sodium chloride 0.9% is given over 8 hours

Outcomes

Primary Outcome Measures

Radiological improvement (CT scan)
Difference between hematoma volume from baseline and 48-hour post treatment scan

Secondary Outcome Measures

National Institutes of Health Stroke Scale
Neurological impairment (score:0-42; 0:favourable outcome)
Barthel index
Disability (score:0-100; 100: independent)
modified rankin scale
dependency (score:0-5; 0: no symptom)

Full Information

First Posted
January 28, 2021
Last Updated
October 3, 2023
Sponsor
Kathmandu Medical College and Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04742205
Brief Title
Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial
Official Title
Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kathmandu Medical College and Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intracerebral hemorrhage is increasingly becoming a major burden in the society because of significant morbidity as well as mortality. Hematoma volume at the time of presentation as well as hematoma expansion and re-bleed or ongoing bleed further deteriorates the patient making a poor prognosis, however at present no therapy targets this pathological process. Though clinical studies do report benefit of using tranexamic acid in spontaneous intracerebral hemorrhage by reducing hematoma expansion rate as well as decreasing ongoing bleed, large randomized controlled trials have not shown any convincing advantage owing to various limitations in their design and methods. However, they uniformly did not find any significant side effect with the use of tranexamic acid. The aim of this study is to test the hypothesis that intravenous tranexamic acid is superior to placebo by reducing hematoma expansion when given within 24 h of spontaneous intracerebral hemorrhage.
Detailed Description
Patients and Methods: Data will be collected (after Nepal Health Research Council approval) for 1 year as patient gets admitted with Intracerebral haemorrhage. 160 spontaneous intracerebral haemorrhage patients presenting within 24 hours of ictus or last known well will be taken in the study. Outcomes of these patients will be calculated to establish a relationship between hematoma expansion, underlying pathology and outcome of the patients. Results: Primary outcome i.e. radiological improvement (CT scan): Difference between hematoma volume with perilesional edema from baseline and 48-hour post treatment scan, hematoma location, and new infarction. Secondary outcomes: Neurological impairment (National Institutes of Health Stroke Scale) at day 7, Outcome: Dependency (modified Ranking Scale), Cognition (Telephone Interview Cognition Score-Modified), and mood (Zung Depression Scale) at days 10 and 90 and 180. Similarly, costs: Length of stay in hospital, readmission, ability to return back to daily activities. Also, Safety endpoints recorded until day 90: Death (cause), venous thromboembolism confirmed by ultrasound, vascular occlusive events (stroke/transient ischemic attack/myocardial infarction/peripheral artery disease), seizures. Serious adverse events (AEs) in first seven days will be analyzed and calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hemorrhage
Keywords
double blind randomized trial, spontaneous intracerebral hemorrhage, tranexamic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
Four 5ml solution of either tranexamic acid 500mg or sodium chloride 0.9% are distributed which cannot be differentiated from the appearance. Loading dose of trial (1g of tranexamic acid in 10ml) or placebo (10 ml of sodium chloride 0.9%) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial or placebo mixed in 500ml sodium chloride 0.9% is given over 8 hours
Arm Title
Sodium Chloride
Arm Type
Placebo Comparator
Arm Description
Four 5ml solution of either tranexamic acid 500mg or sodium chloride 0.9% are distributed which cannot be differentiated from the appearance. Loading dose of trial (1g of tranexamic acid in 10ml) or placebo (10 ml of sodium chloride 0.9%) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial or placebo mixed in 500ml sodium chloride 0.9% is given over 8 hours
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 500 MG
Intervention Description
Loading dose of trial (1g of tranexamic acid in 10ml) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial mixed in 500ml sodium chloride 0.9% is given over 8 hours
Primary Outcome Measure Information:
Title
Radiological improvement (CT scan)
Description
Difference between hematoma volume from baseline and 48-hour post treatment scan
Time Frame
48 hour
Secondary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale
Description
Neurological impairment (score:0-42; 0:favourable outcome)
Time Frame
day 7
Title
Barthel index
Description
Disability (score:0-100; 100: independent)
Time Frame
days 10 and 90, 180
Title
modified rankin scale
Description
dependency (score:0-5; 0: no symptom)
Time Frame
days 10 and 90, 180
Other Pre-specified Outcome Measures:
Title
Death
Description
Number of death
Time Frame
day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients presenting to the emergency department with symptom of hemorrhagic stroke within 24 hours from onset of symptom or last seen well. Patient who had a follow up Exclusion Criteria: Glasgow coma scale <9 after resuscitation (as this can lead to biasness; requires surgery) Contraindication to tranexamic acid, Hemorrhagic stroke secondary to trauma, Hemorrhage was caused by coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bibesh Pokhrel, MS
Phone
+9779849671672
Email
bibeshpokharel@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Regmi, MS
Organizational Affiliation
KMC AmbA
Official's Role
Study Chair
Facility Information:
Facility Name
KMC Teaching Hospital, Kathmandu, Nepal
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
44811
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Thapa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial

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