AzTrials
AzTrials

Spontaneous Intracerebral HemorrhageUKER-ICHNCT03183167

Longitudinal Cohort Study on ICH Care

An observational study of Spontaneous Intracerebral Hemorrhage, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Intracerebral hemorrhage [ICH] is the most feared sub-type of stroke, associated with a high mortality rate up to 50% and thus leaving large proportions of patients in functionally dependent states. In recent years randomized trials have failed to provide an effective intervention to improve functional outcome in ICH. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spontaneous Intracerebral Hemorrhage
How many people
1,076 participants
Where
1 siteGermany
Study dates
1 Jan 2006to 1 Apr 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Spontaneous Primary Intracerebral Hemorrhage

Who may be able to join

  • Spontaneous Primary Intracerebral Hemorrhage

Who cannot join

  • Secondary ICH etiology (i.e. AVM, SAH, SVT, Fistulas, Tumor, Trauma)
  • ICH patients on active anticoagulation (known NOAC intake, INR Level on Admission >1.4)
  • Patients with intraparenchymal hemorrhage after Thrombolysis

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University or Erlangen-Nuremberg

    Erlangen, 91054

Other trials in Germany

About this study

Official title: Universitätsklinikum Erlangen Cohort of Patients With Spontaneous Intracerebral Hemorrhage

Intracerebral hemorrhage [ICH] is the most feared sub-type of stroke, associated with a high mortality rate up to 50% and thus leaving large proportions of patients in functionally dependent states. In recent years randomized trials have failed to provide an effective intervention to improve functional outcome in ICH. Therefore, evidence regarding acute therapeutic interventions as well as secondary treatment approaches is still limited.

The present monocentric longitudinal study on spontaneous ICH patients is based on a prospective institutional stroke registry including all hemorrhagic stroke patients treated at a German University Hospital, Department of Neurology, over a 10 year time frame (2006-2015). The main aim of this investigation, besides analyses of epidemiological aspects, will be (i) to identify possible treatment targets influencing functional outcome, and (ii) to evaluate existing therapeutic strategies in ICH care.

Read the detailed description

Stroke is one of the leading causes for death and disability in the industrialized world. Intracerebral hemorrhage [ICH] represents one sub-type with a rather poor prognosis. As randomized trials of recent years failed to establish an effective treatment strategy in ICH, identification of therapeutic strategies is urgently needed. Furthermore, evidence on commonly carried out management approaches is limited and remains to be specifically established. Roughly, one third of patients experience hematoma enlargement strongly impacting functional outcome, yet hemostatic treatments have not shown to be safe and aggressive blood pressure reductions are safe but not significantly effective. Therefore, improved risk-stratification for patients at high-risk for hematoma growth may increase the effect size of possible interventions. Intraventricular hemorrhage initially present or occurring during hematoma growth may represent another therapeutic target as a potentially treatable outcome predictor, recently studied in the CLEAR-IVH trial. Again, functional outcome was not improved in favour of the intervention emphasizing the need to identify patients who may benefit the most. Furthermore, several management issues remain to be elucidated in critically ill ICH patients, i.e. how to prevent venous thrombosis or systemic thromboembolism, what is the impact of invasive intracranial pressure monitoring, how to prevent or treat peri-hemorrhagic edema and what is the role of surgical approaches?

This observational cohort study will try to strengthen the therapeutic evidence for ICH treatment by generating a large (n>1000) cohort of consecutive ICH patients treated a tertiary care hospital in Germany. Further, collaborative efforts will be undertaken to integrate and compare data from the present study to existing cohorts to validate specific findings. Patients will be identified from an institutional prospective stroke registry by the diagnosis of spontaneous primary ICH during a time period from 2006-2015. Only patients with spontaneous primary ICH will be included, other secondary etiologies will be excluded: i.e. tumors, trauma, vascular malformations, anticoagulation at presentation etc. will be excluded. Clinical data on demographics, medical history, pre-ICH medication exposures and laboratory results will be obtained by medical charts, institutional databases or prospective registries, supplemented by structured interviews or by review of all available medical records. Patient-derived follow-up information will be corroborated by review of pertinent medical records. An estimated total number of greater 1000 patients will be reviewed for this investigation. In detail the following parameters will be evaluated: - prior medical history (including CHADS-VASC-Score, HAS-Bled Score, vascular risk factors), - functional status prior admission (mRS), - neurological admission status (NIHSS, GCS), - imaging characteristics, - time intervals: symptom onset until admission, imaging, therapy initiation, - acute blood pressure management, - complications (hemorrhagic- or ischemic-events, infectious) and treatment (surgical treatment, mode of antithrombotic treatment or prophylaxis of systemic thromboembolism, intraventricular fibrinolysis, etc.), - mortality rates, - functional outcome (mRS);

Being tested
No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional outcome

    dichotomized by modified Rankin Scale 0-3 vs 4-6

    Measured: 90 days

Secondary outcomes (4)

  1. Hematoma enlargement

    ICH volume increase on Follow-up Imaging >33%

    Measured: 24 hours

  2. Intracranial complications

    ischemic and hemorrhagic events

    Measured: 90 days

  3. Extracranial complications

    ischemic and hemorrhagic events

    Measured: 90 days

  4. Functional outcome

    dichotomized by modified Rankin Scale 0-3 vs 4-6

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2017
  2. Study start1 Jan 2006
  3. Primary completion31 Dec 2016
  4. Study completion1 Apr 2017

Resources

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
1,076 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183167
Sponsor's protocol ID
Longitudinal study ICH care
Acronym
UKER-ICH
Status last verified
Jun 2017
First submitted
6 Jun 2017
Last updated
9 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kaertner M, Macha K, Sembill J, Mrochen A, Knott M, Lang S, Lucking H, Kuramatsu JB, Volbers B. Association of prophylactic mannitol administration with perihemorrhagic edema and long-term outcome in patients with intracerebral hemorrhage. BMC Neurol. 2026 Apr 1;26(1):230. doi: 10.1186/s12883-026-04858-w.

    PubMed 41923209

  • Mrochen A, Sprugel MI, Sekita A, Balk S, Haupenthal D, Gerner ST, Lucking H, Doerfler A, Macha K, Schwab S, Kuramatsu JB, Sembill JA. Long-Term Survival, Burden of Disease, and Patient-Centered Outcomes in Maximally Treated Intracerebral Hemorrhage. Ann Clin Transl Neurol. 2025 Jun;12(6):1144-1150. doi: 10.1002/acn3.70048. Epub 2025 Apr 14.

    PubMed 40223467

  • Mrochen A, Song Y, Harders V, Sembill JA, Sprugel MI, Hock S, Lang S, Engelhorn T, Kallmunzer B, Volbers B, Kuramatsu JB. Influence of bundled care treatment on functional outcome in patients with intracerebral hemorrhage. Front Neurol. 2024 Aug 5;15:1357815. doi: 10.3389/fneur.2024.1357815. eCollection 2024.

    PubMed 39161870

  • Sembill JA, Knott M, Xu M, Roeder SS, Hagen M, Sprugel MI, Mrochen A, Borutta M, Hoelter P, Engelhorn T, Rothhammer V, Macha K, Kuramatsu JB. Simplified Edinburgh CT Criteria for Identification of Lobar Intracerebral Hemorrhage Associated With Cerebral Amyloid Angiopathy. Neurology. 2022 May 17;98(20):e1997-e2004. doi: 10.1212/WNL.0000000000200261. Epub 2022 Mar 21.

    PubMed 35314501

  • Sprugel MI, Kuramatsu JB, Volbers B, Saam JI, Sembill JA, Gerner ST, Balk S, Hamer HM, Lucking H, Holter P, Nolte CH, Scheitz JF, Rocco A, Endres M, Huttner HB. Impact of Statins on Hematoma, Edema, Seizures, Vascular Events, and Functional Recovery After Intracerebral Hemorrhage. Stroke. 2021 Mar;52(3):975-984. doi: 10.1161/STROKEAHA.120.029345. Epub 2021 Feb 1.

    PubMed 33517701

  • Roeder SS, Sprugel MI, Sembill JA, Giede-Jeppe A, Macha K, Madzar D, Lucking H, Hoelter P, Gerner ST, Kuramatsu JB, Huttner HB. Influence of the Extent of Intraventricular Hemorrhage on Functional Outcome and Mortality in Intracerebral Hemorrhage. Cerebrovasc Dis. 2019;47(5-6):245-252. doi: 10.1159/000501027. Epub 2019 Jun 18.

    PubMed 31212293

Questions about this trial

What is this clinical trial studying?

An observational study of Spontaneous Intracerebral Hemorrhage, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

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 3 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 9 Jun 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 Germany. 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?

Functional outcome (time frame: 90 days). 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 NCT03183167, which also lists 6 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 9 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in