Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742205
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2021-01-28
Brief Title:
ITCH Trial Protocol for a Randomized Double Blind Placebo-controlled Trial
Sponsor:
Kathmandu Medical College and Teaching Hospital
Organization:
Kathmandu Medical College and Teaching Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 145 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 ie 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 fu data Also Safety endpoints recorded until day 180 Death cause venous thromboembolism confirmed by ultrasound vascular occlusive events stroketransient ischemic attackmyocardial infarctionperipheral artery disease seizures Serious adverse events AEs in first seven days will be analyzed and calculated
Results Primary outcome ie 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 fu data Also Safety endpoints recorded until day 180 Death cause venous thromboembolism confirmed by ultrasound vascular occlusive events stroketransient ischemic attackmyocardial infarctionperipheral artery disease seizures Serious adverse events AEs in first seven days will be analyzed and calculated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None