Acute Management of OAC-ICH Clinical Trial
Official title:
German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage
Intracerebral hemorrhage [ICH] is the most feared complication of anticoagulant therapy [OAC]. Evidence regarding acute therapeutic interventions as well as secondary treatment approaches is still limited. Therefore, this German-wide observational cohort study will retrospectively identify and evaluate all OAC-associated ICH patients that have been admitted to the 20 participating tertiary centres over a 5-year period. The main focus of this investigation, besides epidemiological aspects, will be the (i) acute management of OAC-ICH, (ii) secondary therapy (anticoagulant management) and (iii) long-term outcome after OAC-ICH.
Stroke in general is one of the leading causes for death and disability in the
industrialized world. Cardiac thromboembolisms are a major contributor to ischemic
infarction and the most frequent reason is atrial fibrillation [afib]. The prevalence of
afib is constantly increasing within the ageing population and its established therapy (oral
anticoagulation) increases alongside. Therefore, rates of OAC-ICH are expected to increase
simultaneously. As compared to spontaneous ICH, OAC-ICH is associated with larger
ICH-volumes, an increased mortality and poorer functional outcome. Nevertheless, only
limited evidence is available for the treatment of such severely injured patients. The only
sound benefit is reported for the strategy of "INR-reversal as soon as possible". More
detailed therapeutic approaches and guidelines are not well established. Many questions
regarding the acute treatment strategy remain to be investigated (modus of INR reversal,
prevention of hematoma growth, operative procedures, aso).
Moreover, the most pressing questions that need to be answered relate to coagulation
management after OAC-ICH. Would patients benefit from resumption of OAC? Which patients
would benefit and when? What are the complication rates (thromboembolic versus bleedings)
according to which treatment? How is outcome influenced by the different therapeutic
strategies?
This observational cohort study will try to strengthen the therapeutic evidence for OAC-ICH
treatment by retrospective data-pooling of 20 nation-wide tertiary hospitals in Germany.
Patients will be identified from medical records by the diagnosis of ICH and concomitantly
present intake OAC (INR>1.4) during a time period from 2006-2010. Only patients with ICH
associated to OAC will be included, other secondary cause i.e. tumors, trauma, vascular
malformations etc. will be excluded.
Following parameters will be evaluated: + prior medical history (CHADS-VASC-Score, HAS-Bled
Score, risk factors) functional status prior admission; + Timing of symptoms until -
admission, - imaging, - therapy initiation; + acute therapy (INR reversal, blood pressure,
hematoma growth); + complications and treatment (thrombosis-prophylaxis, infections,
transfusions, etc.); + Mortality rates (discharge, 3 months and 1 year, overall long-term);
+ functional outcome mRS (discharge, 3 months and 1 year, overall long-term); + secondary
prophylaxis (OAC vs. platelet inhibitors); + bleedings versus thromboembolic-events.
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Observational Model: Cohort, Time Perspective: Retrospective