ormothermia in patients with acute cerebral damage - ND

• Conditions: Subarachnoid hemorrhage, traumatic brain injury; MedDRA version: 6.1Level: PTClassification code 10060690

• Registration Number: EUCTR2007-000584-13-IT
• Lead Sponsor: OSPEDALE MAGGIORE DI MILANO (IRCCS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS<8), intubated, mechanically ventilated with intracranical pressure (ICP) and invasive arterial pressure monitoring.
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified