Longitudinal Cohort Study on ICH Care

Spontaneous Intracerebral Hemorrhage Clinical Trial

— UKER-ICH  

Official title:

Universitätsklinikum Erlangen Cohort of Patients With Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183167
• Other study ID #: Longitudinal study ICH care
• Status: Completed
• Phase: N/A
• First received: June 6, 2017
• Last updated: June 8, 2017
• Start date: January 1, 2006
• Est. completion date: April 1, 2017

Study information

• Verified date: June 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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);

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1076
• Est. completion date: April 1, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Spontaneous Intracerebral Hemorrhage

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Germany	University or Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	dichotomized by modified Rankin Scale 0-3 vs 4-6	90 days
Secondary	Hematoma enlargement	ICH volume increase on Follow-up Imaging >33%	24 hours
Secondary	Intracranial complications	ischemic and hemorrhagic events	90 days
Secondary	Extracranial complications	ischemic and hemorrhagic events	90 days
Secondary	Functional outcome	dichotomized by modified Rankin Scale 0-3 vs 4-6	1 year