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geRman-widE mulTicenter Analysis of oRal Anticoagulation-associated intraCerebral hEmorrhage (RETRACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829581
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
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.

Condition or disease Intervention/treatment
OAC-ICH Acute Management of OAC-ICH Resumption of OAC Other: no intervention, only descriptive data analysis

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 1205 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
oral anticoagulation associated intracerebral hemorrhage Other: no intervention, only descriptive data analysis



Primary Outcome Measures :
  1. 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)

  2. Secondary prophylaxis and occurrence of ischemic vs hemorrhagic events [ Time Frame: 1 year ]
  3. Modus of INR reversal [ Time Frame: 72 hours ]
    agent used for INR reversal; timing of INR normalization; occurrence of hemorrhage growth?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with oral anticoagulation (INR>1.4) associated intracerebral hemorrhage
Criteria

Inclusion Criteria:

  • between 2006-2010 in one of the participating centers hospitalized patients with OAC-ICH

Exclusion Criteria:

  • secondary ICH other than OAC-ICH

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Hagen B. Huttner, MD Department of Neurology, University of Erlangen-Nuremberg, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01829581    
Other Study ID Numbers: Multicenter Analysis OAC-ICH
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases