ThrombosisNCT03303820
Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients
An observational study of Thrombosis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in various degrees. This prevalence didn't change since 15-20 years The fact is that the present undernutrition in the admission deteriorates during the hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2016to 31 Aug 2017
- 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
- Adult, Older adult
Study population: patient admitted in hospital for vascular cerebral accident in 2015 with thrombolytic treatment
Who may be able to join
- patient admitted in hospital for vascular cerebral accident in 2015
- thrombolytic treatment
Who cannot join
- no thrombolytic treatment
- transcient ischaemic attack
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in various degrees. This prevalence didn't change since 15-20 years The fact is that the present undernutrition in the admission deteriorates during the hospitalization.
Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the link between the undernutrition the entrance and the evolution of the AVC is at the moment only little known. The purpose is to study the impact of the undernutrition in the entrance to the hospital (undernutrition previous to the AVC), on the gravity and the evolution
- Conditions
- Thrombosis
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rankin score
measurement of Rankin score at the entrance and at the end of hospitalisation
Measured: Day 1; last day of hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start27 May 2016
- Primary completion27 May 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZUBER Mathieu, Professor, Study director, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303820
- Sponsor's protocol ID
- ADIT
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients
- ClinicalTrials.gov ID
- NCT03303820
- Acronym / sponsor ID
- ADIT
- Conditions
- Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 27 May 2016 (actual)
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 6 Oct 2017 (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.
Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in various degrees. This prevalence didn't change since 15-20 years The fact is that the present undernutrition in the admission deteriorates during the hospitalization.
Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the link between the undernutrition the entrance and the evolution of the AVC is at the moment only little known. The purpose is to study the impact of the undernutrition in the entrance to the hospital (undernutrition previous to the AVC), on the gravity and the evolution
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient admitted in hospital for vascular cerebral accident in 2015 with thrombolytic treatment
Key inclusion criteria (2 listed)
- patient admitted in hospital for vascular cerebral accident in 2015
- thrombolytic treatment
Key exclusion criteria (2 listed)
- no thrombolytic treatment
- transcient ischaemic attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rankin score
Time frame: Day 1; last day of hospitalisation
measurement of Rankin score at the entrance and at the end of hospitalisation
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 6 Oct 2017.
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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.
ZUBER Mathieu, Professor study director
GHPSJ
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 Thrombosis, run by Fondation Hôpital Saint-Joseph 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 2 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 6 Oct 2017. 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?
Rankin score (time frame: Day 1; last day of hospitalisation). 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 6 Oct 2017.