NCT03183167

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,076

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

11 years

First QC Date

June 6, 2017

Last Update Submit

June 8, 2017

Conditions

Spontaneous Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

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

    90 days

Secondary Outcomes (4)

  • Hematoma enlargement

    24 hours

  • Intracranial complications

    90 days

  • Extracranial complications

    90 days

  • Functional outcome

    1 year

Interventions

No interventionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Spontaneous Primary Intracerebral Hemorrhage

You may qualify if:

  • Spontaneous Primary Intracerebral Hemorrhage

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University or Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

Related Publications (4)

  • 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.

    PMID: 39161870DERIVED

  • 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.

    PMID: 35314501DERIVED

  • 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.

    PMID: 33517701DERIVED

  • 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.

    PMID: 31212293DERIVED

Study Officials

  • Hagen B. Huttner, MD. PhD.

    University Hospital Erlangen, Department of Neurology, Germany

    PRINCIPAL INVESTIGATOR

  • Joji B. Kuramatsu, MD.

    University Hospital Erlangen, Department of Neurology, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 9, 2017

Study Start

January 1, 2006

Primary Completion

December 31, 2016

Study Completion

April 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)