Actively Recruiting
Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
Led by Christian Medical College and Hospital, Ludhiana, India · Updated on 2026-01-22
3400
Participants Needed
48
Research Sites
217 weeks
Total Duration
On this page
Sponsors
C
Christian Medical College and Hospital, Ludhiana, India
Lead Sponsor
I
Indian Council of Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multicenter, pragmatic randomized, open-label clinical trial aims to assess whether Tranexamic Acid improves outcomes in adult patients with spontaneous intracerebral haemorrhage. The participants presenting within 4.5 hours of the onset of symptoms of stroke with intracerebral haemorrhage confirmed on Computed Tomography (CT Scan) will be randomized into two groups in a 1:1 ratio using a central online randomization. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml 0.9% sodium chloride administered over 45 minutes. Control arm patients will receive standard of care treatment as per the institutional protocol. In both arms, intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive medications, which has to be achieved within one hour and will be maintained over next seven days. The choice of antihypertensive drug will depend on the clinician's preference. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the neurological status will warrant urgent brain imaging. On day 7, the patient will be assessed for their NIHSS score and mRS score. On day 90, quality of life and the functional outcome will be assessed.
CONDITIONS
Official Title
Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged more than 18 years
- Presenting with non-traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
You will not qualify if you...
- Patients with intracerebral hemorrhage caused by anticoagulation, thrombolysis, or known structural abnormalities such as arteriovenous malformation, aneurysm, tumor, venous thrombosis, or hereditary coagulation disorders
- Contraindication to Tranexamic Acid
- Concurrent participation in another clinical trial
- Pre-stroke life expectancy less than 3 months (e.g., advanced metastatic cancer)
- Glasgow Coma Scale score less than 5
- Intracerebral hemorrhage caused by trauma
- Women who are pregnant, breastfeeding, or of childbearing potential at randomization
- Geographical or other factors preventing follow-up for 90 days
- Concurrent or planned treatment with other hemostatic agents
- Intracerebral hemorrhage volume greater than 60 mL as measured by ABC/2 method
AI-Screening
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Trial Site Locations
Total: 48 locations
1
Government General Hospital
Guntur, Andhra Pradesh, India, 522001
Actively Recruiting
2
Lalitha Super Specialty Hospital
Guntur, Andhra Pradesh, India, 522001
Actively Recruiting
3
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, Andhra Pradesh, India, 522004
Actively Recruiting
4
Assam Medical College
Dibrugarh, Assam, India, 786001
Actively Recruiting
5
Guwahati Neurological Research Center
Guwahati, Assam, India, 781006
Actively Recruiting
6
Apollo Excelcare Hospitals
Guwahati, Assam, India, 781033
Actively Recruiting
7
Baptist Christian Hospital
Tezpur, Assam, India, 784001
Actively Recruiting
8
Tezpur Medical College and Hospital
Tezpur, Assam, India, 784153
Actively Recruiting
9
Manipal Hospital
Panjim, Goa, India, 403004
Not Yet Recruiting
10
Shree Krishna Hospital Pramukhswami Medical College
Anand, Gujarat, India, 388325
Actively Recruiting
11
Artemis Hospital
Gurgaon, Haryana, India, 122001
Actively Recruiting
12
All India Institute of Medical Sciences
Bilāspur, Himachal Pradesh, India, 174001
Actively Recruiting
13
Atal Institute of Medical Super Specilities, (AIMSS) Chamiana
Shimla, Himachal Pradesh, India, 171001
Actively Recruiting
14
Manipal Hospital
Bangalore, Karnataka, India, 560017
Not Yet Recruiting
15
Sparsh Superspeciality Hospital
Bangalore, Karnataka, India, 560022
Actively Recruiting
16
National Institute of Mental Health and Neuro-Sciences
Bangalore, Karnataka, India, 560029
Not Yet Recruiting
17
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India, 590010
Actively Recruiting
18
Kasturba Medical College Manipal
Manipal, Karnataka, India, 576104
Actively Recruiting
19
Baby Memorial Hospital
Calicut, Kerala, India, 673004
Actively Recruiting
20
ASTER MIMS Hospital
Calicut, Kerala, India, 673016
Actively Recruiting
21
Amrita Institute for Medical Sciences and Research Center
Kochi, Kerala, India, 682041
Actively Recruiting
22
Government Medical College Trivandrum
Thiruvananthapuram, Kerala, India, 695011
Actively Recruiting
23
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, India, 695011
Actively Recruiting
24
Fortis Hospital Mulund
Mumbai, Maharashtra, India, 400078
Actively Recruiting
25
Holy Spirit Hospital
Mumbai, Maharashtra, India, 400093
Actively Recruiting
26
Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Actively Recruiting
27
Bharati Vidyapeeth DTU Medical College
Pune, Maharashtra, India, 411043
Actively Recruiting
28
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
29
Institute of Human Behaviour and Allied Sciences
New Delhi, National Capital Territory of Delhi, India, 110095
Actively Recruiting
30
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, 751019
Actively Recruiting
31
Guru Gobind Singh Medical College and Hospital
Farīdkot, Punjab, India, 151203
Actively Recruiting
32
Christian Medical College and Hospital, Ludhiana, Punjab
Ludhiana, Punjab, India, 141008
Actively Recruiting
33
PBM Hospital
Bikaner, Rajasthan, India, 334001
Actively Recruiting
34
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, India, 302015
Actively Recruiting
35
Fortis Escorts Hospital
Jaipur, Rajasthan, India, 302017
Actively Recruiting
36
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, India, 600100
Actively Recruiting
37
KG Hospital and Post Graduate Medical Institute Coimbatore
Coimbatore, Tamil Nadu, India, 641018
Actively Recruiting
38
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Tamil Nadu, India, 605006
Actively Recruiting
39
Tirunelveli Medical College
Tirunelveli, Tamil Nadu, India, 627011
Actively Recruiting
40
Christian Medical College Vellore
Vellore, Tamil Nadu, India, 632517
Actively Recruiting
41
CARE Hospitals
Hyderabad, Telangana, India, Hyderabad
Actively Recruiting
42
King George's Medical University
Lucknow, Uttar Pradesh, India, 226003
Actively Recruiting
43
Institute of Medical Sciences of the Banaras Hindu University (BHU)
Varanasi, Uttar Pradesh, India, 221005
Actively Recruiting
44
Institute of Neurosciences
Kolkata, West Bengal, India, 700017
Actively Recruiting
45
Bangur Institute of Neurosciences
Kolkata, West Bengal, India, 700020
Actively Recruiting
46
The Calcutta Medical Research Center
Kolkata, West Bengal, India, 700027
Actively Recruiting
47
Postgraduate Institute for Medical Education and Research
Chandigarh, India, 160012
Actively Recruiting
48
St Stephen's Hospital
Delhi, India, 110054
Actively Recruiting
Research Team
J
Jeyaraj D Pandian, MD DM
CONTACT
A
Atul Phillips, MD FNB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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