Intracerebral HemorrhageAVICHNCT02920645
Multicenter Validation of the AVICH Score
An observational study of Intracerebral Hemorrhage and Arterio-venous Malformation, run by University of Zurich.
Trial summary
The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH. Secondary objectives are the impact of pretreatment of the AVICH score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Arterio-venous Malformation
- What is being tested?
- AVM-related ICH
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2016
- 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: patients that suffered from intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM)
Who may be able to join
- All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
- Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.
Who cannot join
- incomplete data set
- AVM Patients with only SAH or IVH and no ICH
About this study
The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH.
Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.
Read more
Multicentre validation study
Key inclusion criteria:
- All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
- Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.
Key exclusion criteria:
- incomplete data set
- AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH
Read the detailed description
Intracerebral hemorrhage (ICH) is the most common life threatening presentation of brain arteriovenous malformations (AVMs). Several AVM grading systems are available for presurgical risk assessment to help selecting patients for surgery. The most widely accepted and classic grading system is the Spetzler-Martin grading system; however, the recently introduced and externally validated supplemented Spetzler-Martin system seems to have an even better predictive accuracy. The pathophysiology of AVM-related ICH and spontaneous ICH is completely different. It is well known that clinical outcome in patients suffering spontaneous ICH is worse compared with patient outcome after AVM-related ICH. For spontaneous ICH, not related to AVM, several scoring systems exist to predict patient outcome. The most commonly used system is the ICH score. The available ICH scoring systems may not predict outcome in patients with hemorrhage caused by AVM rupture with the highest accuracy possible. Therefore, we examined a new scoring system called the AVM-related ICH score (AVICH score), which predicts patient outcome in the acute setting of AVM rupture. This scoring system is a special adaptation of the supplemented Spetzler-Martin grading system designed for patients presenting with hemorrhage, which includes additional clinical and radiographic information. Based on the area under the receiver operating characteristics curve (AUROC) analysis in this single center analysis, the AVICH score predicts outcome of patients with ruptured AVM and associated ICH better than the ICH score, the Spetzler-Martin, or the supplemented Spetzler-Martin grading system. An external validation is needed before the AVICH score is tested in a prospective multicenter cohort.
The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH.
Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.
Key inclusion criteria:
- All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
- Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.
Key exclusion criteria:
- incomplete data set
- AVM Patients with only SAH or IVH and no ICH
September, 1, 2016 - September, 30, 2016
- individual ethical approval each center (if needed)
- data collection (n = approximately 30/center)
November, 1, 2016 - November, 31, 2016
- data analysis (Zurich)
- Being tested
- AVM-related ICH
- Keywords
- ICH, AVM, intracerebral hemorrhage, arterio-venous malformation, AVICH
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVM-related ICHOther
| Study group | Role | What they receive |
|---|---|---|
| AVM-related ICH patients | patients that suffered intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM) Receives: Other: AVM-related ICH |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurological long-term outcome (modified Ranking Scale, mRS)
Measured: up to 3 years at last follow-up
Secondary outcomes (2)
neurological outcome (modified Ranking Scale, mRS)
Measured: 3 months after ICH
neurological outcome (modified Ranking Scale, mRS)
Measured: 1 year after ICH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan-Karl Burkhardt, MD, Principal investigator, Department of Neurosurgery, University Hospital Zurich, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920645
- Sponsor's protocol ID
- AVICH-V1.1
- Acronym
- AVICH
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Neidert MC, Lawton MT, Mader M, Seifert B, Valavanis A, Regli L, Bozinov O, Burkhardt JK. The AVICH Score: A Novel Grading System to Predict Clinical Outcome in Arteriovenous Malformation-Related Intracerebral Hemorrhage. World Neurosurg. 2016 Aug;92:292-297. doi: 10.1016/j.wneu.2016.04.080. Epub 2016 May 2.
PubMed 27150647Neidert MC, Lawton MT, Kim LJ, Nerva JD, Kurisu K, Ikawa F, Konczalla J, Dinc N, Seifert V, Habdank-Kolaczkowski J, Hatano T, Hayase M, Podlesek D, Schackert G, Wanet T, Glasker S, Griessenauer CJ, Ogilvy CS, Kneist A, Sure U, Seifert B, Regli L, Bozinov O, Burkhardt JK. International multicentre validation of the arteriovenous malformation-related intracerebral haemorrhage (AVICH) score. J Neurol Neurosurg Psychiatry. 2018 Nov;89(11):1163-1166. doi: 10.1136/jnnp-2017-316259. Epub 2017 Oct 6.
PubMed 28986471
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation of the AVICH Score
- ClinicalTrials.gov ID
- NCT02920645
- Acronym / sponsor ID
- AVICH / AVICH-V1.1
- Keywords
- ICH, AVM, intracerebral hemorrhage, arterio-venous malformation, AVICH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Sep 2016 (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.
The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH.
Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.
Multicentre validation study
Key inclusion criteria:
- All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
- Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.
Key exclusion criteria:
- incomplete data set
- AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH
Detailed description
Intracerebral hemorrhage (ICH) is the most common life threatening presentation of brain arteriovenous malformations (AVMs). Several AVM grading systems are available for presurgical risk assessment to help selecting patients for surgery. The most widely accepted and classic grading system is the Spetzler-Martin grading system; however, the recently introduced and externally validated supplemented Spetzler-Martin system seems to have an even better predictive accuracy. The pathophysiology of AVM-related ICH and spontaneous ICH is completely different. It is well known that clinical outcome in patients suffering spontaneous ICH is worse compared with patient outcome after AVM-related ICH. For spontaneous ICH, not related to AVM, several scoring systems exist to predict patient outcome. The most commonly used system is the ICH score. The available ICH scoring systems may not predict outcome in patients with hemorrhage caused by AVM rupture with the highest accuracy possible. Therefore, we examined a new scoring system called the AVM-related ICH score (AVICH score), which predicts patient outcome in the acute setting of AVM rupture. This scoring system is a special adaptation of the supplemented Spetzler-Martin grading system designed for patients presenting with hemorrhage, which includes additional clinical and radiographic information. Based on the area under the receiver operating characteristics curve (AUROC) analysis in this single center analysis, the AVICH score predicts outcome of patients with ruptured AVM and associated ICH better than the ICH score, the Spetzler-Martin, or the supplemented Spetzler-Martin grading system. An external validation is needed before the AVICH score is tested in a prospective multicenter cohort.
The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH.
Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.
Key inclusion criteria:
- All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
- Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.
Key exclusion criteria:
- incomplete data set
- AVM Patients with only SAH or IVH and no ICH
September, 1, 2016 - September, 30, 2016
- individual ethical approval each center (if needed)
- data collection (n = approximately 30/center)
November, 1, 2016 - November, 31, 2016
- data analysis (Zurich)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVM-related ICH patients | – | Other: AVM-related ICHpatients that suffered intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients that suffered from intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM)
Key inclusion criteria (2 listed)
- All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
- Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.
Key exclusion criteria (2 listed)
- incomplete data set
- AVM Patients with only SAH or IVH and no ICH
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 |
|---|---|---|
| AVM-related ICH | Other | AVM-related ICH patients |
Primary outcome
neurological long-term outcome (modified Ranking Scale, mRS)
Time frame: up to 3 years at last follow-up
2 secondary outcomes
neurological outcome (modified Ranking Scale, mRS)
Time frame: 3 months after ICH
neurological outcome (modified Ranking Scale, mRS)
Time frame: 1 year after ICH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Results publication: PubMed 27150647Neidert MC, Lawton MT, Mader M, Seifert B, Valavanis A, Regli L, Bozinov O, Burkhardt JK. The AVICH Score: A Novel Grading System to Predict Clinical Outcome in Arteriovenous Malformation-Related Intracerebral Hemorrhage. World Neurosurg. 2016 Aug;92:292-297. doi: 10.1016/j.wneu.2016.04.080. Epub 2016 May 2.
- Derived from this study: PubMed 28986471Neidert MC, Lawton MT, Kim LJ, Nerva JD, Kurisu K, Ikawa F, Konczalla J, Dinc N, Seifert V, Habdank-Kolaczkowski J, Hatano T, Hayase M, Podlesek D, Schackert G, Wanet T, Glasker S, Griessenauer CJ, Ogilvy CS, Kneist A, Sure U, Seifert B, Regli L, Bozinov O, Burkhardt JK. International multicentre validation of the arteriovenous malformation-related intracerebral haemorrhage (AVICH) score. J Neurol Neurosurg Psychiatry. 2018 Nov;89(11):1163-1166. doi: 10.1136/jnnp-2017-316259. Epub 2017 Oct 6.
- 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.
Jan-Karl Burkhardt, MD principal investigator
Department of Neurosurgery, University Hospital Zurich, University of Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage and Arterio-venous Malformation, run by University of Zurich.
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: status not confirmed, as of the sponsor's last update on 30 Sep 2016. 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?
Results are not available in the source record.
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?
neurological long-term outcome (modified Ranking Scale, mRS) (time frame: up to 3 years at last follow-up). 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 NCT02920645, which also lists 2 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 30 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.