Acquired Brain Injury Including StrokePRES'SMRNCT06983314
Prescription Patterns of Antidepressants, Analgesics, and Antiepileptics Drugs in Adult With Acquired Brain Injury
An observational study of Acquired Brain Injury Including Stroke, run by University Hospital, Caen at 1 site in France.
Trial summary
Acquired brain injury (ABI), primarily caused by stroke and traumatic brain injury (TBI), leads to severe disabilities and requires complex pharmacological management during post-acute rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury Including Stroke
- What is being tested?
- Observation
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 1 Jul 2024
- 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: The study population consists of adult patients diagnosed with acquired brain injury (ABI) who were hospitalized in two rehabilitation centers in Normandy, France, between November 1, 2020, and October 31, 2023. Eligible patients were required to have passed through an acute care department before being admitted to the rehabilitation center. Only patients with ABI as the primary diagnosis, according to the PMSI (French medical information system), were included. The study focused on patients who received new prescriptions for specific pharmacological classes (antidepressants, antiepileptics, and analgesics) either during acute care or within the first month of rehabilitation hospitalization. Patients were excluded if they had pre-existing prescriptions for these drugs prior to ABI, or if they did not receive new prescriptions for these drugs during the study period. The final study population was selected based on these inclusion and exclusion criteria.
Who may be able to join
- Adults hospitalized in a rehabilitation center for acquired brain injury (ABI) after passing through an acute care department.
- ABI must be the primary diagnosis in the PMSI (French medical information system).
- The pharmacological classes of interest (antidepressants, antiepileptics, analgesics) must have been introduced during acute care or within the first month of hospitalization in the rehabilitation center.
Who cannot join
- Patients who did not receive new prescriptions for the pharmacological classes of interest during acute care or the first month of hospitalization in the rehabilitation center.
- Patients who were already prescribed these drugs prior to the ABI.
- Patients who were not hospitalized immediately after discharge from acute care (patients must have been transferred directly from acute care to the rehabilitation center, without spending time in another department or at home).
- Patients who were transferred to an emergency department during rehabilitation and did not return to the rehabilitation center.
- Patients who died during hospitalization or were discharged against medical advice.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Caen (Centre Hospitalier Universitaire de Caen, France)
Caen, 14000
About this study
Official title: Prescription Patterns of Antidepressants, Analgesics, and Antiepileptics Drugs in Adult Patients With Acquired Brain Injury Hospitalized in Rehabilitation Center Following Acute Care: a Bicentric Retrospective Study
Acquired brain injury (ABI), primarily caused by stroke and traumatic brain injury (TBI), leads to severe disabilities and requires complex pharmacological management during post-acute rehabilitation. The lack of dedicated guidelines and regular treatment re-evaluation increases the risk of adverse drug reactions (ADRs).
Retrospective, bicentric study in two rehabilitation centers in Normandy, France, from November 1, 2020, to October 31, 2023, to describe prescription patterns of antidepressants, antiepileptics, and analgesics, as well as potential drug-related complications.
- Conditions
- Acquired Brain Injury Including Stroke
- Being tested
- Observation
- Keywords
- Acquired Brain Injury, Stroke, Traumatic Brain Injury, Rehabilitation, Prescription Patterns, Antidepressants, Antiepileptics, Analgesics, Drug Complications, Adverse Drug Reactions, Drug-Drug Interactions, Pharmacological Management, Post-acute Care
- Medical subject headings
- Brain Injuries, Stroke, Brain Injuries, Traumatic, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of pharmacological prescriptions in patients with ABI
| Study group | Role | What they receive |
|---|---|---|
| Group | Patients with Acquired Brain Injury (ABI) receiving prescribed antidepressants, antiepileptics, and analgesics during hospitalization. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Paterns and rates of antidepressants, antiepileptics and analgesics
Proportion of patients with at least one prescription of antidepressants, antiepileptics, or analgesics retrieved from medical records, described at three time points: (1) pre-existing usual prescriptions prior to acute care hospitalization, (2) prescriptions at discharge from acute care, and (3) prescriptions at discharge from rehabilitation.
This outcome is purely descriptive. No clinical events are measured. No measurement tools are used. Data are extracted retrospectively from medical records.
Measured: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Secondary outcomes (5)
Total number of drugs listed per prescription type
To analyze the average number of drugs per prescription, categorized into three types: usual prescription, discharge from acute care, and discharge from rehabilitation.
Unit of Measure:
Number of drugs per prescription Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
Measured: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Most frequently prescribed drug classes per prescription type
To identify the top prescribed pharmacological classes (e.g., using ATC classification) within usual prescriptions, acute discharge prescriptions, and rehabilitation discharge prescriptions.
Unit of Measure:
Number of prescriptions per drug class Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
Measured: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Analysis of specific drugs, their indications, and therapeutic management
To describe the most frequently prescribed drugs in the three target classes, assess whether their indications comply with official labelling, and detail any therapeutic adjustments during the rehabilitation stay (e.g., dosage changes, discontinuation).
Unit of Measure:
Number of prescriptions assessed for compliance and change Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
Measured: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days)
Number of potential drug-drug interactions identified
To identify and count potential pharmacokinetic or pharmacodynamic drug-drug interactions involving antidepressants, antiepileptics, or analgesics, in the context of all prescribed medications.
Unit of Measure:
Number of potential drug-drug interactions per patient Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
Measured: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Rate of suspected Adverse Drug Reactions (ADRs) and therapeutic consequences
To identify suspected Adverse Drug Reactions (ADRs) reported in medical records and describe the related clinical decisions (e.g., discontinuation, switch, dose adjustment).
Unit of Measure:
Number of ADRs reported and management decisions documented Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
Measured: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Nov 2020
- Primary completion31 Oct 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury Including StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983314
- Sponsor's protocol ID
- 4726
- Acronym
- PRES'SMR
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Patterns of Antidepressants, Analgesics, and Antiepileptics Drugs in Adult Patients With Acquired Brain Injury Hospitalized in Rehabilitation Center Following Acute Care: a Bicentric Retrospective Study
- ClinicalTrials.gov ID
- NCT06983314
- Acronym / sponsor ID
- PRES'SMR / 4726
- Conditions
- Acquired Brain Injury Including Stroke
- Keywords
- Acquired Brain Injury, Stroke, Traumatic Brain Injury, Rehabilitation, Prescription Patterns, Antidepressants, Antiepileptics, Analgesics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 21 May 2025 (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.
Acquired brain injury (ABI), primarily caused by stroke and traumatic brain injury (TBI), leads to severe disabilities and requires complex pharmacological management during post-acute rehabilitation. The lack of dedicated guidelines and regular treatment re-evaluation increases the risk of adverse drug reactions (ADRs).
Retrospective, bicentric study in two rehabilitation centers in Normandy, France, from November 1, 2020, to October 31, 2023, to describe prescription patterns of antidepressants, antiepileptics, and analgesics, as well as potential drug-related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Other: ObservationPatients with Acquired Brain Injury (ABI) receiving prescribed antidepressants, antiepileptics, and analgesics during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with acquired brain injury (ABI) who were hospitalized in two rehabilitation centers in Normandy, France, between November 1, 2020, and October 31, 2023. Eligible patients were required to have passed through an acute care department before being admitted to the rehabilitation center. Only patients with ABI as the primary diagnosis, according to the PMSI (French medical information system), were included. The study focused on patients who received new prescriptions for specific pharmacological classes (antidepressants, antiepileptics, and analgesics) either during acute care or within the first month of rehabilitation hospitalization. Patients were excluded if they had pre-existing prescriptions for these drugs prior to ABI, or if they did not receive new prescriptions for these drugs during the study period. The final study population was selected based on these inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Adults hospitalized in a rehabilitation center for acquired brain injury (ABI) after passing through an acute care department.
- ABI must be the primary diagnosis in the PMSI (French medical information system).
- The pharmacological classes of interest (antidepressants, antiepileptics, analgesics) must have been introduced during acute care or within the first month of hospitalization in the rehabilitation center.
Key exclusion criteria (5 listed)
- Patients who did not receive new prescriptions for the pharmacological classes of interest during acute care or the first month of hospitalization in the rehabilitation center.
- Patients who were already prescribed these drugs prior to the ABI.
- Patients who were not hospitalized immediately after discharge from acute care (patients must have been transferred directly from acute care to the rehabilitation center, without spending time in another department or at home).
- Patients who were transferred to an emergency department during rehabilitation and did not return to the rehabilitation center.
- Patients who died during hospitalization or were discharged against medical advice.
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 |
|---|---|---|
| ObservationObservation of pharmacological prescriptions in patients with ABI | Other | Group |
Primary outcome
Prescription Paterns and rates of antidepressants, antiepileptics and analgesics
Time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Proportion of patients with at least one prescription of antidepressants, antiepileptics, or analgesics retrieved from medical records, described at three time points: (1) pre-existing usual prescriptions prior to acute care hospitalization, (2) prescriptions at discharge from acute care, and (3) prescriptions at discharge from rehabilitation. This outcome is purely descriptive. No clinical events are measured. No measurement tools are used. Data are extracted retrospectively from medical records.
5 secondary outcomes
Total number of drugs listed per prescription type
Time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Most frequently prescribed drug classes per prescription type
Time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Analysis of specific drugs, their indications, and therapeutic management
Time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days)
Number of potential drug-drug interactions identified
Time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Rate of suspected Adverse Drug Reactions (ADRs) and therapeutic consequences
Time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
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 21 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acquired Brain Injury Including Stroke, run by University Hospital, Caen at 1 site 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 3 inclusion and 5 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 21 May 2025. 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 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.
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?
Prescription Paterns and rates of antidepressants, antiepileptics and analgesics (time frame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).). 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 21 May 2025.