Traumatic Brain InjuryPhase 4NCT00491192
Normothermia in Patients With Acute Cerebral Damage
A Phase 4 study testing Diclofenac in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
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 in patients with acute cerebral damage admitted to ICU. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- What is being tested?
- Diclofenac
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring
Who cannot join
- Know adverse reactions with NSAI
- Platelets count < 20,000/dl
- Gastric or duodenal ulceration in active phase
- Hepatic insufficiency, cirrhosis or previous liver transplant
- Acute or chronic renal insufficiency
- Coronary insufficiency, acute myocardial infarct in the previous 6 month
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- Barbiturate coma
- Patients in therapy with acetylsalicylic acid, lithium, digoxin, methotrexate and cyclosporin.
- Known or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, 20122
Laura Ghisoni, MD
Katia Canavesi, MD
About this study
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 in patients with acute cerebral damage admitted to ICU.
Read the detailed description
Pyrexia can exacerbate ischemic neuronal damage and physiological dysfunction after traumatic brain injury and subarachnoid hemorrhage.Fever also represent an important issue occurring in 78% of patients with acute cerebral damage admitted to intensive care unit (ICU). For those patients, normothermia is actually recommended in order to reduce secondary cerebral damage and to control intracranial pressure, that are known to worsen long term prognosis. Our primary endpoint is to maintain normothermia in patients with acute cerebral damage (axillary temperature < 38°C or internal temperature < 38,8°C) administering diclofenac. We will also investigate the corresponding behaviour of intracranial pressure and cerebral perfusion pressure.
Comparison(s): We will compare two different doses of subcutaneous diclofenac (0,35 mg/kg - 1/3 a vial - vs 0,5 mg/Kg - 1/2 vial) to continuous intravenous of 0,48 mg/kg diclofenac for 12 hours.
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Being tested
- Diclofenac
- Keywords
- Fever, Acute cerebral damage, Normothermia, Diclofenac, ICU, Outcome, Intracranial pressure, Cerebral perfusion pressure, Traumatic brain injury, Subarachnoid hemorrhage
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of normothermia
Measured: within 14 days from ICU admission
Secondary outcomes (1)
Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.
Measured: Within 14 days from ICU admission/Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJun 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Nino Stocchetti, MD, Study director, Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491192
- Sponsor's protocol ID
- 1575
- Status last verified
- Jun 2007
- First submitted
- 25 Jun 2007
- Last updated
- 20 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermia in Patients With Acute Cerebral Damage
- ClinicalTrials.gov ID
- NCT00491192
- Acronym / sponsor ID
- 1575
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Keywords
- Fever, Acute cerebral damage, Normothermia, Diclofenac, ICU, Outcome, Intracranial pressure, Cerebral perfusion pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jun 2009
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in patients with acute cerebral damage admitted to ICU.
Detailed description
Pyrexia can exacerbate ischemic neuronal damage and physiological dysfunction after traumatic brain injury and subarachnoid hemorrhage.Fever also represent an important issue occurring in 78% of patients with acute cerebral damage admitted to intensive care unit (ICU). For those patients, normothermia is actually recommended in order to reduce secondary cerebral damage and to control intracranial pressure, that are known to worsen long term prognosis. Our primary endpoint is to maintain normothermia in patients with acute cerebral damage (axillary temperature < 38°C or internal temperature < 38,8°C) administering diclofenac. We will also investigate the corresponding behaviour of intracranial pressure and cerebral perfusion pressure.
Comparison(s): We will compare two different doses of subcutaneous diclofenac (0,35 mg/kg - 1/3 a vial - vs 0,5 mg/Kg - 1/2 vial) to continuous intravenous of 0,48 mg/kg diclofenac for 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring
Key exclusion criteria (9 listed)
- Know adverse reactions with NSAI
- Platelets count < 20,000/dl
- Gastric or duodenal ulceration in active phase
- Hepatic insufficiency, cirrhosis or previous liver transplant
- Acute or chronic renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac | Drug | – |
Primary outcome
Maintenance of normothermia
Time frame: within 14 days from ICU admission
1 secondary outcome
Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.
Time frame: Within 14 days from ICU admission/Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Stocchetti, MD study director
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nino Stocchetti, MD (0039.02.5503.5517, stocchet@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of normothermia (time frame: within 14 days from ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2007.