A comparative study of HyperHAES (7.2% NACL and 6% hydroxyethyl starch) and 20% mannitol in the treatment of elevated intracranial pressure after brain injry

INTERVENTION: 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 placebo: Intravenous use CONDITION: elevated intracranial pressure after brain injury PRIMARY OUTCOME: Main Objective: The aim of the study is to compare the efficacy hyperhaes with mannitol on reducing elevated intracranial pressure (ICP) after head injury. ; ; Primary end point(s): The primary outcome measures will be ICP reduction below the treatment level of 20mmHg and the duration of this effect. 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. 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