Subarachnoid hemorrhage, traumatic brain injury MedDRA version: 6.1 Level: PT Classification code 10060690
Conditions
Interventions
Trade Name: DICLOREUM*INIET 6F 75MG/3ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Diclofenac
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
OSPEDALE MAGGIORE DI MILANO (IRCCS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Known adverse reactions with NSAID 2) Platelets count < 20,000/dl 3) Gastric or duodenal ulceration in active phase 4) Hepatic insufficiency, cirrhosis or previuos liver transplant 5) Acute or chronic renal insufficiency 6) Coronary insufficiency, acute myocardial infarct in the previous 6 month 7) Barbiturate coma 8) Patients in therapy with acetylsalicylic acid, lithium, digoxin, methotrexate, and cyclosporin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of our study is to verify wherever normothermia (achieved with diclofenac administration) may improve intracranial pressure control and may limit secondary cerebral damage thus positively influencing outcome.;Secondary Objective: Characterization of diclofenac dose and administration (subcutaneous or endovenous) for temperature control in ICU. Subcutaneous administration 0,35 mg/kg (1/3 a vial)of diclofenac has the same effects as other preparations on temperature, but a less impact on arterial pressure.;Primary end point(s): Maintenance of normothermia (axillary temperature < 38?C or internal temperature < 38,3?C)administering diclofenac. Corresponding behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six months outcome. | — |
Countries
Italy
Outcome results
None listed