geRman-widE mulTicenter Analysis of oRal Anticoagulation-associated intraCerebral hEmorrhage

Acute Management of OAC-ICH Clinical Trial

— RETRACE  

Official title:

German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829581
• Other study ID #: Multicenter Analysis OAC-ICH
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: February 25, 2014
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1205
• Est. completion date: January 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• secondary ICH other than OAC-ICH

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Management of OAC-ICH
• Cerebral Hemorrhage
• OAC-ICH
• Resumption of OAC

Intervention

Other:
• no intervention, only descriptive data analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term functional outcome	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)	1 year	No
Primary	Secondary prophylaxis and occurrence of ischemic vs hemorrhagic events		1 year	No
Primary	Modus of INR reversal	agent used for INR reversal; timing of INR normalization; occurrence of hemorrhage growth?	72 hours	No

External Links

•   List of all participating centers