elevated intracranial pressure after brain injury
Conditions
Interventions
Trade Name: HypeHAES
Product Name: freeflex
Product Code: hyperhaes
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the pl
Sponsors
Research and Development Office, Royal Infirmary of Edinburgh
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria:- 1. Brain injured patient with ICP monitoring device 2. Intracranial pressure greater than 20mmhg for 5minutes Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients under 16 years of age 2. Pregnancy (if appropriate, females of child bearing age will be tested for pregnancy) 3. Patients who have their ICP treatment threshold set above 20mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to compare the efficacy hyperhaes with mannitol on reducing elevated intracranial pressure (ICP) after head injury. ;Secondary Objective: The secondary outcomes will be comparison of serum sodium, osmolality and haematocrit and urine sodium and osmolality. Cerebral perfusion pressure (CPP), mean arterial pressure (MAP) and central venous pressure (CVP) will also be examined.;Primary end point(s): The primary outcome measures will be ICP reduction below the treatment level of 20mmHg and the duration of this effect. | — |
Countries
United Kingdom
Outcome results
None listed