TBI (Traumatic Brain Injury)NCT05807503
Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury
An observational study of TBI (Traumatic Brain Injury), run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Cerebrolysin
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2020to 30 Nov 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 56 patients in age from 28 to 91 years old, 33% female, 66% male, bleeding during the TBI: * epidural: 16/56 (27%) * subdural : 26/56 (45%) * into deep structures: 14/56 (23%)
Who may be able to join
- TBI diagnosis
- admission to ICU
- age >18 y
Who cannot join
- initially lethal injury
- age <18 y
Trial locations and contacts
1 site in 1 country.
Poland1 site
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 70-204
About this study
Official title: Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial
Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Cerebrolysin
- Keywords
- TBI, neuroprotective treatment, Cerebrolysin, neuromonitoring, NIRS, ICP, ONDS
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Cerebrolysin administration in short period of time after TBI
| Study group | Role | What they receive |
|---|---|---|
| A with Cerebrolysin administration | Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated with Cerebrolysin administration in addition to standard ICU protocols. Receives: Drug: Cerebrolysin | |
| B without Cerebrolysin administration | Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated without Cerebrolysin administration according to standard ICU protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale GOS
Glasgow Outcome Scale
Measured: 2 months
Length Of Stay LOS
Length Of Stay
Measured: 2 months
Mortality
Death of the patient
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Feb 2020
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaudyna Kojder, Pomeranian Medical University Szczecin
- Investigators
- Konrad Jarosz, Principal investigator, The Department Of Specialist Nursing, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807503
- Sponsor's protocol ID
- 02/10/2020
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: more information after individual contacting with investigators
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial
- ClinicalTrials.gov ID
- NCT05807503
- Acronym / sponsor ID
- 02/10/2020
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- TBI, neuroprotective treatment, Cerebrolysin, neuromonitoring, NIRS, ICP, ONDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 11 Apr 2023 (actual)
- 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.
Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A with Cerebrolysin administration | – | Drug: CerebrolysinGroup of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated with Cerebrolysin administration in addition to standard ICU protocols. |
| B without Cerebrolysin administration | – | –Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated without Cerebrolysin administration according to standard ICU protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 56 patients in age from 28 to 91 years old, 33% female, 66% male, bleeding during the TBI: * epidural: 16/56 (27%) * subdural : 26/56 (45%) * into deep structures: 14/56 (23%)
Key inclusion criteria (3 listed)
- TBI diagnosis
- admission to ICU
- age >18 y
Key exclusion criteria (2 listed)
- initially lethal injury
- age <18 y
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 |
|---|---|---|
| CerebrolysinCerebrolysin administration in short period of time after TBI | Drug | A with Cerebrolysin administration |
Primary outcome
Glasgow Outcome Scale GOS
Time frame: 2 months
Glasgow Outcome Scale
Length Of Stay LOS
Time frame: 2 months
Length Of Stay
Mortality
Time frame: 2 months
Death of the patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Undecided. more information after individual contacting with investigators
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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.
Konrad Jarosz principal investigator
The Department Of Specialist Nursing, Pomeranian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury), run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Apr 2023. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale GOS (time frame: 2 months). The study lists 3 primary outcomes in all. 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 11 Apr 2023.