geRman-widE mulTicenter Analysis of oRal Anticoagulation-associated intraCerebral hEmorrhage (RETRACE)
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|ClinicalTrials.gov Identifier: NCT01829581|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : February 26, 2014
|Condition or disease||Intervention/treatment|
|OAC-ICH Acute Management of OAC-ICH Resumption of OAC||Other: no intervention, only descriptive data analysis|
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.
|Study Type :||Observational|
|Actual Enrollment :||1205 participants|
|Official Title:||German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||January 2014|
|oral anticoagulation associated intracerebral hemorrhage||
Other: no intervention, only descriptive data analysis
- 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?
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): NCT01829581
|Principal Investigator:||Hagen B. Huttner, MD||Department of Neurology, University of Erlangen-Nuremberg, Germany|