Longitudinal Cohort Study on ICH Care
Longitudinal Cohort Study on ICH Care
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.
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);
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