CTRI/2023/10/058309
Not yet recruiting
Phase 3
Randomized controlled trial comparing the outcome of surgical decision-making guided by a bleed-to-brain ratio in computerized tomography scans versus a group where the decision-making is done randomly in the management of traumatic intraparenchymal hematomas. - NI
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: S068- Other specified intracranial injuries
- Sponsor
- Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 to 50 who had sustained head trauma in the last 48 hours and the CT scan shows intraparenchymal bleeding where the treating team is not certain whether to operate or manage conservatively immediately.
Exclusion Criteria
- •Severe head trauma where the patient is not expected to survive 48 hours with or without surgery (for example, GCS E1M2V1 with bilaterally dilated pupils).
- •Patients with other life\-threatening systemic injuries like flail chest, abdominal hollow viscus perforation
- •Depressed fracture or decompressive craniectomy where a BBR cannot be calculated accurately
- •Patients with pre\-existing neurological deficits like stroke or previous major head trauma.
- •Patients with pure extradural bleeding or acute subdural hematoma without an intraparenchymal bleed(contusion).
- •If the patient cannot be taken up for surgery in the next 12 hours due to logistic reasons like a long waiting list for emergency surgery.
- •A patient with a clear indication for surgery, say, by brain trauma foundation guidelines.
- •Pre\-existing fatal/serious medical disease like advanced renal failure, liver failure, or cardiac disease which could by itself threaten life in the next three months, etc.
Outcomes
Primary Outcomes
Not specified
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