Clinical trial NCT04742205: ITCH Trial: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cerebral Hemorrhage
Keywords: double blind randomized trial
spontaneous intracerebral hemorrhage
tranexamic acid
Lead sponsor: Kathmandu Medical College and Teaching Hospital
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 are being collected as patient gets admitted with Intracerebral haemorrhage. 154 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 (NIHSS), Disability (Barthel index), dependency (mRS) on day of discharge. mRS at day 30. Cognition (Telephone Interview Cognition Score-Modified), dependency (mRS) at days 90 and 180. Similarly, costs of treatment between two groups, length of stay in hospital and f/u data. Also, Safety endpoints recorded until day 180: 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.

Eligibility criteria: 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 \<8 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

Primary outcomes:
measure: Radiological improvement (CT scan)
timeFrame: 48 hour
Secondary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: day 10
measure: Barthel index
timeFrame: days 10
measure: modified rankin scale
timeFrame: days 10 and 30, 90, 180
Other outcomes:
measure: Death
timeFrame: day 180
Locations:
city: Kathmandu
country: Nepal
facility: KMC Teaching Hospital, Kathmandu, Nepal
state: Bagmati
Study officials:
affiliation: KMC AmbA
name: Deepak Regmi, MS
role: STUDY_CHAIR
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