Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

Launched by CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, LUDHIANA, INDIA · Apr 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Tranexamic Acid can help improve outcomes for adults who have experienced a spontaneous intracerebral hemorrhage, which is a type of stroke caused by bleeding in the brain. The trial involves giving some patients Tranexamic Acid through an IV, while others will receive standard care. Both groups will also have their blood pressure carefully managed to help prevent further complications. Doctors will monitor the participants’ brain health using CT scans and assess their recovery and quality of life over time.

To be eligible for this trial, participants need to be adults over 18 years old who have had a stroke caused by bleeding in the brain within the last 4.5 hours. Some people may not qualify, such as those who have certain underlying health issues or are currently pregnant or breastfeeding. Throughout the trial, participants can expect close monitoring and follow-ups to ensure their safety and to gather information about how well the treatment works. This study aims to provide valuable insights into whether Tranexamic Acid can make a difference for patients recovering from this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
• Exclusion Criteria:
• • 1. Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis, known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumour or venous thrombosis or due to known hereditary coagulation disorders. An underlying structural abnormality does not need to be excluded before enrolment, but where known, patients should not be recruited.
• • 2. Known allergies to Tranexamic Acid.
• • 3. Premorbid modified Rankin scale score \>4 at the time of enrollment.
• • 4. Concurrent participation in another drug or device trial.
• • 5. Pre stroke life expectancy \<3 months (e.g. advanced metastatic cancer).
• • 6. Glasgow coma scale \<7.
• • 7. ICH secondary to trauma.
• • 8. Women pregnant, or breastfeeding at randomization.
• • 9. Planned surgery for ICH within 24 hours.
• • 10. Concurrent or planned treatment with any other haemostatic agents.
• • 11. ICH volume \> 60 ml as measured by the ABC/2 method on CT Scan (The size of the haematoma will be calculated by the ABC method using the formula (A x B x C)/2, in which "A" is the largest diameter of the hematoma in the CT slice with the largest area of ICH, "B" is the largest diameter of the haemorrhage perpendicular to the line "A"; and "C" is the number of slices with haematoma times the slice thickness; this formula yields haematoma volume in cubic centimetres).