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Multicenter Analysis of Oral Anticoagulant-associated ICH - Part Two

NCT03093233 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1369

Last updated 2024-05-16

No results posted yet for this study

Summary

Intracerebral hemorrhage \[ICH\] is the most feared complication of oral anticoagulation \[OAC\], yet therapeutic strategies are limited reflected by overall weak guideline recommendations. Studies investigating acute interventions especially in patients with ICH taking non-vitamin-K-oral-anticoagulants \[NOAC\] remain inconclusive. Further, acute management issues in OAC-ICH patients (hematoma evacuation surgery, prevention of acute thromboembolic events, intraventricular fibrinolysis) still need to be investigated. Therefore, this observational study (RETRACE-II) represents the follow-up investigation to RETRACE (German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage, study-period 2006-2010, NCT01829581), now spanning a study-period from 2011 until 2015 with 19 participating tertiary care centers nation-wide in Germany. Data pooling of the two RETRACE studies, altogether including more than 2500 patients treated at 22 centers over a 10 year period will allow statistically appropriate analyses of different outcomes.

Conditions

  • Anticoagulation Associated (VKA & NOAC) Intracerebral Hemorrhage

Interventions

OTHER

no intervention

only descriptive data analysis

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Hagen B. Huttner, MD. · University Hospital Erlangen, Department of Neurology, Germany

  • Joji B. Kuramatsu, MD. · University Hospital Erlangen, Department of Neurology, Germany

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-04-04
Completion
2016-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093233 on ClinicalTrials.gov