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Longitudinal Cohort Study on ICH Care (UKER-ICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183167
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.


Condition or disease Intervention/treatment
Spontaneous Intracerebral Hemorrhage Other: No intervention

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);

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Study Type : Observational
Actual Enrollment : 1076 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Universitätsklinikum Erlangen Cohort of Patients With Spontaneous Intracerebral Hemorrhage
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Functional outcome [ Time Frame: 90 days ]
    dichotomized by modified Rankin Scale 0-3 vs 4-6


Secondary Outcome Measures :
  1. Hematoma enlargement [ Time Frame: 24 hours ]
    ICH volume increase on Follow-up Imaging >33%

  2. Intracranial complications [ Time Frame: 90 days ]
    ischemic and hemorrhagic events

  3. Extracranial complications [ Time Frame: 90 days ]
    ischemic and hemorrhagic events

  4. Functional outcome [ Time Frame: 1 year ]
    dichotomized by modified Rankin Scale 0-3 vs 4-6



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Spontaneous Primary Intracerebral Hemorrhage
Criteria

Inclusion Criteria:

  • Spontaneous Primary Intracerebral Hemorrhage

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183167


Locations
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Germany
University or Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03183167    
Other Study ID Numbers: Longitudinal study ICH care
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases