Intracerebral HemorrhageICHCatNCT03247049
Prognosis in Intracerebral Hemorrhage. The ICHCat Score in Primary Care.
An observational study of Intracerebral Hemorrhage and Outcome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
The clinical evidence shows that patients with a first episode of intracerebral hemorrhage (ICH) are increasingly old and with greater comorbidity with a recognized impact over mortality. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Intracerebral Hemorrhage, Outcome, Survival
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2015to 28 Jul 2017
- How long will I take part?
- 10 Years
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cohort with an episode of ICH in the period April 1, 2006 to Setember 30, 2016.
Who may be able to join
- Have been suffered a Intracranial Hemorrhage
Who cannot join
- <15 and >90 year-old
About this study
Official title: Predicting Long Term Survival in Patients With Primary Intracerebral Hemorrhage. Development and Validation of the ICHCat in Primary Care.
The clinical evidence shows that patients with a first episode of intracerebral hemorrhage (ICH) are increasingly old and with greater comorbidity with a recognized impact over mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention to identify those patients with favorable criteria that can benefit from possible treatments; but also after hospital discharge, in primary care where the prediction should facilitate the organization and management of a wide variety of resources: familiar, health and social welfare. Even though there are different scales that predict mortality, these are not sufficiently useful in choosing a treatment or do not provide sufficient data to the family to decide.
Due to the characteristics of the population with ICH described in these works, it seems useful to propose a prognostic index (ICHCat) to identify the variables associated to its incidence and mortality and that, in addition, to make adjustments in the comparisons of the survival between different series of patients or different treatment modalities in primary care.
Read the detailed description
The authors carried out a multicentric and retrospective study of a cohort with an episode of ICH in the period between 2006-2016. The objective of this phase is to design a predictive index (ICHCat) of mortality in patients with an episode of ICH. Patient outcome was followed until death all causes or study end (30.09.2016) since date of ICH in the electronic health record. All people included were managed by the Public Health System in Catalonia. Registry information was collected from the government-run healthcare provider responsible for all inpatient care in the county.
Predictor Variables
Predictor variables were considered if they were viewed as commonly measured and available in primary care and with potential evidence of an association with ICH risk. Candidate variables included:
Sex: woman (0) man (1) Age: <80 year-old (1), ≥80 year-old (2). Number CCP criteria: <4 (0) ≥4 (1). Charlson comorbidity index. Short version. Current medications were asked about during the home visit and confirmed in medical records. Polypharmacy (defined as five or more daily medications): <5 (0), between 5-9 (1), and ≥10 (2). Oral anticoagulants (acenocumarol or warfarin) with TTR ≥60% (1), if TRT <60% (2) or New Oral Anticoagulants NOACs (0). Antidepressants and/or, sedating or other drugs affecting the neurologic system: man (1), woman (2). If there was a diagnostic of "atrial fibrillation", CHA2DS2VASC and HAS-BLED scores were included.
Recurrent falls or fall risk: no (0), yes (1). Hypertension not controlled by therapy (≥ 160/90 mmHg): no (0), yes (1). BP was measured as an average of separated follow-up measurements last six months.
Alcoholism abuse vs dependence: no (0), yes (1) Presence de cognitive impairment: a disease-specific diagnosis of cognitive impairment and/or prescription of specific treatment, without specification of sub-type or severity, was used and mesured by Pfeiffer test [2]: [0-2 errors] = Intact Intellectual Functioning (1); [≥3 errors] = Mild to severe Intellectual Impairment (2)].
Presence de disability: score in [Barthel ≥60 (1) <60 (2)] or in [Rankin <4 (1) 5(2)] were used to assess dependence in ADL Functional status: (0) Autonomus (1) Residual with caretaker (2) Dependence with caretaker (3) Long stay
Socio familiar risk: score in Gijon[18] scale 10-14 (1) ≥15 (2)]
Primary Outcome Given the limited survival, the primary outcome was death all causes occurring within the 5-year follow-up after the ICH episode.
Predictions of ICH mortality risk were based on Cox proportional-hazards regression models. All potential predictors were considered in a multivariate logistic regression, and a backward step selection procedure was carried out to pick the variables that composed the best model. Subsequently design a predictive model of multivariate Cox regression analysis to define the weight of each of the pathologies in the mortality. To assign the weight according to the value HR took into account only those with a HR ≥1.2 in the multivariate model approximating the value of HR to the nearest whole number:
- HR between 1.20 and 1.49 scored with 1.
- HR between 1.50 and 2.49 with 2.
- HR between 2.50 and 3.49 received 3, and so on.
The final score for each patient (ICH) was made up of the sum of their scores by age and comorbidity. To check the validity of the index we define the following levels of mortality risk:
- Low risk: 0-1 points.
- Medium Risk: from 2 to 5 points.
- High Risk: of 6 or more points.
The authors estimate the survival probability of each risk group according to the Kaplan-Meier method and compared these curves using the Log-Rank test. It will be used ROC curves i the AUC to assess the ability of the index ICH to perform properly the assignment of patients to different risk groups. The hazard ratio according to the proportional hazards model categorized in their levels of risk, in order to observe the increase in the risk of death that occurs from a risk group to the next. The statistical analysis consisted of a multivariate logistic regression model. The model selection has been caried out with an AIC-led forward step selection method. To ensure internal validity, 20% of data has been discarded in the phase of constructing the model and only used to assess model performance using ROC curves and the AUC.
In a second phase, there will be a retrospective study of validation in the cohort of patients PCC of the territory with an episode of ICH.
- Conditions
- Intracerebral Hemorrhage, Outcome, Survival, Primary Care, Hazard Risk
- Medical subject headings
- Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Death all causes
Death all causes
Measured: Within 5 years follow-up after episode ICH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start27 Jul 2015
- Primary completion31 Dec 2016
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Principal investigator, Josep Lluís Clua Espuny, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- V Francisco Gil-Guillen, PhD, Study chair, Universidad Miguel Hernandez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247049
- Sponsor's protocol ID
- IDIAP Jordi Gol code P16/087
- Acronym
- ICHCat
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All IPD will be shared after definitive validation
Publications
Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.
PubMed 27113062Lorman-Carbo B, Clua-Espuny JL, Muria-Subirats E, Ballesta-Ors J, Gonzalez-Henares MA, Fernandez-Saez J, Martin-Lujan FM; on behalf Ebrictus Research Group. Complex chronic patients as an emergent group with high risk of intracerebral haemorrhage: an observational cohort study. BMC Geriatr. 2021 Feb 5;21(1):106. doi: 10.1186/s12877-021-02004-4.
PubMed 33546615Gonzalez-Henares MA, Clua-Espuny JL, Lorman-Carbo B, Fernandez-Saez J, Queralt-Tomas L, Muria-Subirats E, Ballesta-Ors J, Gil-Guillen JV. Risk of Long-Term Mortality for Complex Chronic Patients with Intracerebral Hemorrhage: A Population-Based e-Cohort Observational Study. Adv Ther. 2020 Feb;37(2):833-846. doi: 10.1007/s12325-019-01206-y. Epub 2019 Dec 26.
PubMed 31879838
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Long Term Survival in Patients With Primary Intracerebral Hemorrhage. Development and Validation of the ICHCat in Primary Care.
- ClinicalTrials.gov ID
- NCT03247049
- Acronym / sponsor ID
- ICHCat / IDIAP Jordi Gol code P16/087
- Conditions
- Intracerebral Hemorrhage, Outcome, Survival, Primary Care, Hazard Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 11 Aug 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.
The clinical evidence shows that patients with a first episode of intracerebral hemorrhage (ICH) are increasingly old and with greater comorbidity with a recognized impact over mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention to identify those patients with favorable criteria that can benefit from possible treatments; but also after hospital discharge, in primary care where the prediction should facilitate the organization and management of a wide variety of resources: familiar, health and social welfare. Even though there are different scales that predict mortality, these are not sufficiently useful in choosing a treatment or do not provide sufficient data to the family to decide.
Due to the characteristics of the population with ICH described in these works, it seems useful to propose a prognostic index (ICHCat) to identify the variables associated to its incidence and mortality and that, in addition, to make adjustments in the comparisons of the survival between different series of patients or different treatment modalities in primary care.
Detailed description
The authors carried out a multicentric and retrospective study of a cohort with an episode of ICH in the period between 2006-2016. The objective of this phase is to design a predictive index (ICHCat) of mortality in patients with an episode of ICH. Patient outcome was followed until death all causes or study end (30.09.2016) since date of ICH in the electronic health record. All people included were managed by the Public Health System in Catalonia. Registry information was collected from the government-run healthcare provider responsible for all inpatient care in the county.
Predictor Variables
Predictor variables were considered if they were viewed as commonly measured and available in primary care and with potential evidence of an association with ICH risk. Candidate variables included:
Sex: woman (0) man (1) Age: <80 year-old (1), ≥80 year-old (2). Number CCP criteria: <4 (0) ≥4 (1). Charlson comorbidity index. Short version. Current medications were asked about during the home visit and confirmed in medical records. Polypharmacy (defined as five or more daily medications): <5 (0), between 5-9 (1), and ≥10 (2). Oral anticoagulants (acenocumarol or warfarin) with TTR ≥60% (1), if TRT <60% (2) or New Oral Anticoagulants NOACs (0). Antidepressants and/or, sedating or other drugs affecting the neurologic system: man (1), woman (2). If there was a diagnostic of "atrial fibrillation", CHA2DS2VASC and HAS-BLED scores were included.
Recurrent falls or fall risk: no (0), yes (1). Hypertension not controlled by therapy (≥ 160/90 mmHg): no (0), yes (1). BP was measured as an average of separated follow-up measurements last six months.
Alcoholism abuse vs dependence: no (0), yes (1) Presence de cognitive impairment: a disease-specific diagnosis of cognitive impairment and/or prescription of specific treatment, without specification of sub-type or severity, was used and mesured by Pfeiffer test [2]: [0-2 errors] = Intact Intellectual Functioning (1); [≥3 errors] = Mild to severe Intellectual Impairment (2)].
Presence de disability: score in [Barthel ≥60 (1) <60 (2)] or in [Rankin <4 (1) 5(2)] were used to assess dependence in ADL Functional status: (0) Autonomus (1) Residual with caretaker (2) Dependence with caretaker (3) Long stay
Socio familiar risk: score in Gijon[18] scale 10-14 (1) ≥15 (2)]
Primary Outcome Given the limited survival, the primary outcome was death all causes occurring within the 5-year follow-up after the ICH episode.
Predictions of ICH mortality risk were based on Cox proportional-hazards regression models. All potential predictors were considered in a multivariate logistic regression, and a backward step selection procedure was carried out to pick the variables that composed the best model. Subsequently design a predictive model of multivariate Cox regression analysis to define the weight of each of the pathologies in the mortality. To assign the weight according to the value HR took into account only those with a HR ≥1.2 in the multivariate model approximating the value of HR to the nearest whole number:
- HR between 1.20 and 1.49 scored with 1.
- HR between 1.50 and 2.49 with 2.
- HR between 2.50 and 3.49 received 3, and so on.
The final score for each patient (ICH) was made up of the sum of their scores by age and comorbidity. To check the validity of the index we define the following levels of mortality risk:
- Low risk: 0-1 points.
- Medium Risk: from 2 to 5 points.
- High Risk: of 6 or more points.
The authors estimate the survival probability of each risk group according to the Kaplan-Meier method and compared these curves using the Log-Rank test. It will be used ROC curves i the AUC to assess the ability of the index ICH to perform properly the assignment of patients to different risk groups. The hazard ratio according to the proportional hazards model categorized in their levels of risk, in order to observe the increase in the risk of death that occurs from a risk group to the next. The statistical analysis consisted of a multivariate logistic regression model. The model selection has been caried out with an AIC-led forward step selection method. To ensure internal validity, 20% of data has been discarded in the phase of constructing the model and only used to assess model performance using ROC curves and the AUC.
In a second phase, there will be a retrospective study of validation in the cohort of patients PCC of the territory with an episode of ICH.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort with an episode of ICH in the period April 1, 2006 to Setember 30, 2016.
Key inclusion criteria (1 listed)
- Have been suffered a Intracranial Hemorrhage
Key exclusion criteria (1 listed)
- <15 and >90 year-old
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
Death all causes
Time frame: Within 5 years follow-up after episode ICH
Death all causes
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 16 Aug 2017.
- Results publication: PubMed 27113062Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.
- Derived from this study: PubMed 33546615Lorman-Carbo B, Clua-Espuny JL, Muria-Subirats E, Ballesta-Ors J, Gonzalez-Henares MA, Fernandez-Saez J, Martin-Lujan FM; on behalf Ebrictus Research Group. Complex chronic patients as an emergent group with high risk of intracerebral haemorrhage: an observational cohort study. BMC Geriatr. 2021 Feb 5;21(1):106. doi: 10.1186/s12877-021-02004-4.
- Derived from this study: PubMed 31879838Gonzalez-Henares MA, Clua-Espuny JL, Lorman-Carbo B, Fernandez-Saez J, Queralt-Tomas L, Muria-Subirats E, Ballesta-Ors J, Gil-Guillen JV. Risk of Long-Term Mortality for Complex Chronic Patients with Intracerebral Hemorrhage: A Population-Based e-Cohort Observational Study. Adv Ther. 2020 Feb;37(2):833-846. doi: 10.1007/s12325-019-01206-y. Epub 2019 Dec 26.
- Individual participant dataSharing planned: Undecided. All IPD will be shared after definitive validation
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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.
V Francisco Gil-Guillen, PhD study chair
Universidad Miguel Hernandez
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage and Outcome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Death all causes (time frame: Within 5 years follow-up after episode ICH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247049, which also lists 3 linked publications.
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 16 Aug 2017.