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Personalized Prophylactic Antiepileptic Treatment by Valproate in Patients with Moderate or Severe Traumatic Brain Injury

Personalized Prophylactic Antiepileptic Treatment by Valproate in Patients with Moderate or Severe Traumatic Brain Injury

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16007687
Enrollment
Unknown
Registered
2016-01-01
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy

Interventions

rapid metabolism:sodium valproate 0.4 q12h
poor metabolism:sodium valproate 0.4 q12h

Sponsors

Huahan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 16-65, male or female; 2. GCS 4-10, or GCS progressively decrease to 4-10; 3. Closure head injury; 4. Hemodynamic stable prior to enrollment, the systolic blood pressure> 110 mm Hg, diastolic blood pressure> 60 mm Hg, 5. heart rate <120 beats/min; 6. Conservative treatment of patients served within 24 hours after injury, surgical patients carry out surgery within 24 hours.

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Sedation treatment is necessary; 3. Just a short coma after injury, when the ambulance arrived at the scene or in hospital the patients turned clear consciousness; 4. Open brain injury or penetrating trauma; 5. Systolic blood pressure 120 beats / min, and cannot be corrected within 30 minutes; 6. Bilateral mydriasis with no light reflex; 7. Other parts of the body trauma AIS score> = 4; 8. Persistent hypoxemia (oxygen saturation <94% and greater than 30 minutes); 9. Unable to carry out neurophysiological monitoring after admission or surgery.

Design outcomes

Primary

MeasureTime frame
serum valproate concentration;seizure attack;prognosis (GOS);

Countries

China

Contacts

Public ContactYirui
15197533@qq.com+86 18121079766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 9, 2026