Severe Head InjuryPhase 2/3NCT00152685
High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury
A Phase 2/3 study testing human serum albumin in people with Severe Head Injury, run by University Hospital, Angers at 3 sites in France.
Trial summary
Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Severe Head Injury
- What is being tested?
- human serum albumin
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- severe head injury (GCS < 9) Next of kin informed consent
Who cannot join
- Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2< 300 mmHg) Blood loss > 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Surgical intensive care. CHU
Angers, Cedex 9, 49993
ter Minassian Aram, MD, PhD, 33 (0)2 4135 39 51, arterminassian@chu-angers.fr
Ter Minassian Aram, MD, PhD
- Not yet recruiting
Neurosurgical intensive care. CHU Le Kremlin Bicêtre
Le Kremlin-Bicêtre, 94275
Vigue Bernard, 33 (0)1 45213441, bernard.vigue@bct.ap-hop-paris.fr
Vigue Bernard, MD, PhD
- Recruiting
Neurosurgical intensive care. CHU de Nancy
Nancy, 54035
Audibert Gérard, MD, PhD, 33 (0)3 83 85 14 03, g.audibert@chu-nancy.fr
Audibert Gérard, Md, PhD
About this study
Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.
- Conditions
- Severe Head Injury
- Being tested
- human serum albumin
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human serum albuminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the daily median value of intracranial pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Head InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 2/3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Ter Minassian Aram, MD, PhD, Principal investigator, Universitary hospital of AngersAudibert Gérard, MD, PhD, Study chair, Universitary hospital of NancyVigue Bernard, MD, PhD, Study chair, Universitary hospital of Le Kremlin Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152685
- Sponsor's protocol ID
- CP 02-04
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury
- ClinicalTrials.gov ID
- NCT00152685
- Acronym / sponsor ID
- CP 02-04
- Conditions
- Severe Head Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital, AngersOther government
- First posted
- 9 Sep 2005 (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.
Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- severe head injury (GCS < 9) Next of kin informed consent
Key exclusion criteria (1 listed)
- Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2< 300 mmHg) Blood loss > 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion
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 |
|---|---|---|
| human serum albumin | Drug | – |
Primary outcome
Reduction of the daily median value of intracranial pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2005.
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The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
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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.
Ter Minassian Aram, MD, PhD principal investigator
Universitary hospital of Angers
Audibert Gérard, MD, PhD study chair
Universitary hospital of Nancy
Vigue Bernard, MD, PhD study chair
Universitary hospital of Le Kremlin Bicêtre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing human serum albumin in people with Severe Head Injury, run by University Hospital, Angers at 3 sites in France.
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 1 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 1 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ter Minassian Aram, MD, PhD (33 (0)2 41353951, arterminassian@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the daily median value of intracranial pressure. 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 1 Dec 2005.