NCT Number: NCT01829581
geRman-widE mulTicenter Analysis of oRal Anticoagulation-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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- between 2006-2010 in one of the participating centers hospitalized patients with OAC-ICH
Exclusion criteria
- secondary ICH other than OAC-ICH
Treatment and study plan
Primary outcomes
-
Long-term functional outcome
Time frame: 1 year
- In-hospital mortality
- Functional status at discharge
- Functional short-term outcome (modified Rankin Scale at 3 months)
- Functional long-term outcome (modified Rankin Scale at 12 months)
-
Secondary prophylaxis and occurrence of ischemic vs hemorrhagic events
Time frame: 1 year
-
Modus of INR reversal
Time frame: 72 hours
agent used for INR reversal; timing of INR normalization; occurrence of hemorrhage growth?
Sponsors and collaborators
Lead sponsor
University of Erlangen-Nürnberg Medical School
Other
Registry information
Official study title
German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage
Acronym: RETRACE
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2014
- First posted
- Apr 11, 2013
- Registry last updated
- Feb 26, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.