Diffuse Axonal Injury. Diffuse traumatic brain injury
Conditions
Interventions
Intervention 1: Intervention group: Intravenous infusion of the target dose of 200 micrograms of BDNF-containing exosomes to each patient once every 3 weeks and 3 times during the course. Intervention
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: . Ages 15 to 75 years, GCS score of 5 to 12 within the first 24 hours of injury and no need for craniotomy at any time after admission. 2. Have diffuse axonal injury due to trauma. 3. Patients admitted to the emergency department with GCS score = 8 and TBI from a motor vehicle collision (MVC) are included in the study. 4. No life-threatening illness prior to head injury. However, individuals with stable medical conditions may be permitted to enter the study at the discretion of the investigator. 5. Legal representative or guardian of the subject, by giving written informed consent on behalf of the patient, is able to receive medication.
Exclusion criteria
Exclusion criteria: . Patients, their guardians or legal administrators unwilling to cooperate in the study 2. Subjects had received any other experimental drug within one monthprior to injury 3. Patients with known spinal cord injury 4. Patients with severe ischemic heart disease or congestive heart failure, myocardial infarction, chronic hypertension, cancer, or any other serious illness determined by the investigator, which would affect the evaluation of treatment 5. Having multiple traumas (chest, abdomen, etc.) that could compromise the evaluation of treatment in the opinion of the investigator 6. Subjects with penetrating head injury 7. Subjects with chronic steroid use 9. Patients with renal failure 10. Pregnancy 11. Death within the first 72 hours after injury 12. Acute infection (temperature above 39°C) 13. Brain death 8. Previous major cerebrovascular event, TBI, brain tumor 14. Patients who underwent emergency craniotomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing the effect of BDNF-containing exosomes on the level of consciousness in patients with diffuse axonal injury. Timepoint: 12 hours after injection to 21 days after infusion. Method of measurement: Changes in the Glasgow Coma Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmirali Khodashenas limoni
Mazandaran University of Medical Sciences
Outcome results
None listed