Status:
TERMINATED
Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension
Lead Sponsor:
Hospital Universitari Son Dureta
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
15-75 years
Phase:
PHASE3
Brief Summary
Objective: to assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury...
Eligibility Criteria
Inclusion
- Patients with a severe closed head injury and a post-resuscitation Glasgow Coma Scale (GCS) score below or equal to 8
- Age between 15 and 76 years (inclusive)
- High ICP (\> 20 mm Hg) refractory to first-tier therapeutic measures according to BTF guidelines (1)
- Hemodynamic stability defined as a systolic blood pressure of at least 100 mm Hg or above at the moment of entering the trial
- Written informed consent obtained from next-of-kin or the patient's legally authorized representative
Exclusion
- Previously known ischemic heart failure (Ejection fraction \< 35%)
- Pregnancy
- bilateral dilated and unreactive pupils and a GCS of 3
- Intolerance to barbiturates
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00622570
Start Date
May 1 2002
End Date
December 1 2007
Last Update
February 25 2008
Active Locations (1)
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1
Son Dureta Hospital
Palma, Balearic Island, Spain, 07014