A trial of bleed-to-brain ratio in CT scans to help surgeons make better decisions in head trauma.

Phase 3

• Conditions: Health Condition 1: S068- Other specified intracranial injuries

• Registration Number: CTRI/2023/10/058309
• Lead Sponsor: Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality of patients of the two groups. <br/ ><br> <br/ ><br>To determine if the outcome at three months, as assessed by the extended Glasgow outcome scale (GOSE), is superior in the BBR group compared to that in the control group. <br/ ><br> <br/ ><br>(Either or both of the two co-primary outcomes must be statistically significant to say that the trial is positive. The sample size will be calculated using the first co-primary outcome, which should power for the other co-primary outcome)Timepoint: The first time point of the in-hospital mortality will be if and when the patient dies in the hospital or at three months, whichever is earlier. <br/ ><br> <br/ ><br>The second time point: Three months. To determine if the outcome at three months, as assessed by the extended Glasgow outcome scale (GOSE), is superior in the BBR group compared to that in the control group. <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To determine the outcome in terms of in-hospital mortality and GOSE at three months of patients who were randomly decided to be operated on early compared to those who were conservatively managed. (Analysis within the control arm) <br/ ><br>Timepoint: Three months after trauma;To find if the outcome in terms of in-hospital mortality and the GOSE at three months of patients who were operated on early (both by random chance and by the BBR) is better than those who were conservatively managed? (Analysis of all operated patients versus conserved patients) <br/ ><br>Timepoint: At discharge from the hospital and at three months.