An observational study in Intracranial Hemorrhages, sponsored by University Hospital, Essen. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University Hospital, Essen · Observational
The multicenter, prospective, observational, non-interventional study conducted in German Stroke Units is investigating patients with intracranial hemorrhage (ICH) under effective anticoagulation with rivaroxaban or apixaban.
The aim of the study is to analyze under routine conditions wether the volume increase of ICH under treatment with rivaroxaban and apixaban can be reduced with the antidote andexanet alfa. Thus, data of patients under effective treatment with rivaroxaban or apixaban and treated with andexanet alfa at baseline will be assessed at the time of onset of ICH, during the hospital stay and during a follow-up by telephone at 30 and 90 days after hospital discharge.
The main objective is defined as the change in size or volume of the hematoma by computed tomography (CT) or magnetic resonance imaging (MRI) in patients with ICH under effective treatment with rivaroxaban and apixaban, who are treated with andexanet alfa. Further objectives comprise evaluations concerning the functional status according to modified Rankin Scale (mRS), changes in the National Institutes of Health Stroke Scale (NIHSS), and occurrences of ICH or new intraventricular bleeding as well as mortality rates.
199 studies on the registry are indexed under Intracranial Hemorrhages; 64 are open to participants now.
This study's enrollment of 141 is below the median of 240 across 87 observational studies indexed under Intracranial Hemorrhages.
Browse Intracranial Hemorrhages studies →University Hospital, Essen is the lead sponsor of 111 studies on the registry; 35 are open to participants now.
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Patients with anticoagulating therapy with rivaroxaban or apixaban admitted with a clinically symptomatic ICH will be included in the study if they have been treated with andexanet alfa. A repeat CT or MRI between 12-72h after initial imaging to assess size and volume of bleeding corresponds to the standard treatment.
The option to include patients under anticoagulating therapy edoxaban will be evaluated during the course of the study in case a marketing authorization of andexanet alfa for patients under edoxaban will be received.
Exclusion Criteria:
Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa
Change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
The primary endpoint is the change in size (specified as ml or cm\^3) of the intracranial bleeding evaluated by first CT or MRI between 12-72 hours after initial CT or MRI; further imaging in case of worsened health condition
Time frame: 12-72 hours after initial CT or MRI, further imaging in case of worsened health condition
Functional status according to modified Rankin Scale (mRS)
Functional status acc. to modified Rankin Scale (mRS) before ICH, at admission, at discharge, after 30 days, and after 90 days. The mRS ranges from grade 0 (no symptoms) to grade 6 (dead)
Time frame: before ICH, at admission, at discharge, after 30 days, and after 90 days
Mortality rate
Mortality rate after 7, 30 and 90 days, and intra-hospital mortality rate
Time frame: after 7, 30 and 90 days und during hospital stay
Rate of worsened health condition
Rate of worsened health condition defined as change in NIHSS of ≥4 pts compared to initial NIHSS or worsening of NIHSS level of consciousness ≥1 point or increase of the volume of the intracranial bleeding or new intraventricular bleeding or death
Time frame: At hospital admission and additionally at 24 hours and 72 hours after admission
Change in severity of stroke
Change in severity of stroke based on the National Institutes of Health Stroke Scale (NIHSS) 72 hours after admission
Time frame: 72 hours after admission
Assessment of effective anticoagulation at baseline
Assessment of effective anticoagulation at baseline using PoC anti-fXa assay, intra-hospital decision making for Andexanet alfa administration
Time frame: at baseline
Clinical course and outcomes of patients
Hemostasis will be assessed by coagulation parameters (activated partial thrombin time (aPTT), thrombin time (TT), International Normalized Ratio (INR)) at admission, re-bleeding and thrombotic events (e.g. myocardial infarction, ischemic stroke, deep vein thrombosis) will be assessed by AE reporting performed from admission to hospital to discharge
Time frame: Coagulation parameters will be recorded at hospital admission. Thrombotic events and re-bleeding will be recorded from the date of hospital admission until discharge. The average length of hospital stay is expected to be 10 days
Re-dosing and re-anticoagulation therapy
Resumption of antithrombotic therapy in hospital (incl. type, start date and dose of anticoagulation therapy)
Time frame: The assessement of re-dosing and re-anticoagulation therapy will take place from the date of hospital admission until the date of discharge. The average length of hospital stay is expected to be 10 days.
Health care resource utilization (including ICU length of stay)
Data regarding ICU length of stay and on resource utilization (Intubated on arrival, Mechanical ventilation, ICH-evacuation surgery, External ventricular drainage, Intraventricular lysis, Osmotherapy)
Time frame: Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.
Safety endpoints
Assessment of non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Will be recorded at hospital admission, at 24 and 72 hours after admission, at discharge. The average length of hospital stay is expected to be 10 days (depends on the severity of disease and cannot be specifically defined).
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Essen