AzTrials
AzTrials

HemorrhageNCT05898412

Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya

An observational study of Hemorrhage, run by AstraZeneca at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals. Currently there is limited information on the patient characteristics and outcomes of patients who are treated with andexanet alfa in The Netherlands and how it is used. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhage
What is being tested?
Andexanet alfa
How many people
217 participants
Where
1 siteNetherlands
Study dates
6 Oct 2023to 25 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalized patients >18 years of age treated with at least one dose of andexanet alfa

Who may be able to join

  • Age ≥ 18 years
  • Received at least one dose of andexanet alfa

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Research Site

    Amsterdam

Other trials in Netherlands

About this study

Official title: Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa

This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals. Currently there is limited information on the patient characteristics and outcomes of patients who are treated with andexanet alfa in The Netherlands and how it is used. This is of interest for treating clinicians because there is a need for a patient profile, also due to the on par position of andexanet alfa with PCC in the Dutch national guideline.

Analysis of the data showed that 14 patients of the 218 patients included in the study (6.4%) experienced a thrombotic event (TE) within 30 days after treatment with andexanet alfa. The protocol was amended to allow for an in depth analysis of the 14 TE cases.

Read the detailed description

The direct oral anticoagulants (DOAC) rivaroxaban and apixaban inhibit factor Xa (FXa) and are widely used in clinical practice, due to the ease of administration, lack of need for frequent monitoring and dose adjustment and an improved safety profile. However, reversal of the anticoagulant effect of these FXa inhibitors (FXai) can be acutely required in case of serious bleeding events, like intracranial hemorrhage (ICH).

Ondexxya® (andexanet alfa) has been approved and is available in the Netherlands since 2019. Andexanet alfa is a modified FXa with no coagulant activity. It has a high binding affinity to DOACs and can therefore be used as reversal agent against DOACs. However, andexanet alfa is not used in all Dutch centers. In some hospitals, instead of andexanet alfa, nonspecific agents are used to manage FXai-associated ICH bleeding, like four-factor prothrombin complex concentrate (4F-PCC).

Due to the on par position of andexanet alfa and 4F-PCC in the Dutch multidisciplinary antithrombotic guideline, there is no clear patient profiling for the use of andexanet alfa for Dutch clinicians.

The lack of randomized clinical trials comparing the efficacy and safety of andexanet alfa and 4F-PCC also does not help to provide clarity. There is real world evidence data available (Coleman et al. 2020; Cohen et al. 2022; Costa et al. 2022) but these studies uses data from the US and the UK, and consistently report a superior effectiveness of andexanet alfa over 4F-PCC. However, there is considerable variation in the reported effectiveness between these studies, with mortality rate ranging from 4% to 15.3%. Potentially, differences in methodology and sample size, in addition to patient populations and bleeding locations varying between analyses, have resulted in this variation. Additionally, anecdotal information indicates that in some cases andexanet alfa is administered after 4F-PCC fails.

Therefore, the aim of the present analysis is to characterize the patient population that received andexanet alfa in the Dutch healthcare system. Also, we aim to describe clinical outcomes in patients treated with andexanet alfa in daily clinical practice in the Netherlands.

Providing real world data on the patient characteristics and outcomes of andexanet alfa treated patients in the Netherlands, may support clinicians in the future identification of the patient who benefit most of treatment with andexanet alfa.

The protocol was amended to allow for an in-depth analysis of the 14 individual cases who experienced a TE within 30 days after treatment with andexanet alfa, in order to establish the temporal relationships and clinical impact/outcome of this event on the patient, stratified by risk factors for the occurrence and outcome of the TE.

The results will be shown in a 'swimmers plot', showing the events relative to the onset of the major bleed and the clinical outcome of the TE, including risk classification based on the presence of co-morbidities and several risk factors such as TE and HF in medical history, weight/BMI, BP, restart DOAC, info on initial hemostasis, ICH/Chadvasc score, etc.

Conditions
Hemorrhage
Being tested
Andexanet alfa
Keywords
Observational, Retrospective, Major bleeding, Andexanet alfa, Factor Xa inhibitor, Patient characteristics, Treatment strategy, Outcomes
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Andexanet alfaDrug

    Patients treated with andexanet alfa

Study groups in NCT05898412
Study groupRoleWhat they receive
Andexanet alfaHospitalized patients treated with andexanet alfa
Receives: Drug: Andexanet alfa
Thrombotic EventHospitalized patients treated with andexanet alfa who experienced a thrombotic event (TE) within 30 days
Receives: Drug: Andexanet alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient characteristics

    At baseline the following patient characteristics will be described: age, sex, type of bleeding (ICH, GI or other), concomittant medication, FXai indication, type and dose, comorbidities, GCS at admission (for ICH only), eGFR and Hb, type of hospital.

    For 14 TE cases: weight, BMI anti-FXa level, type of blood transfusion, baseline haematoma volume (ICH only), bloodpressure parameters (initial, 1 hr, 2 hr, mean arterial pressure, 24hr control), pulse, noradrenalin, ICH score/Chadvasc score, do not resuscitate status, info on initial hemostasis that could inform on prognosis (if available from CT) will be described

    Measured: Baseline (which is the date andexanet alfa is administered, i.e. indexdate)

Secondary outcomes (6)

  1. Andexanet alfa dose

    Dose of andexanet alfa in mg

    Measured: Baseline

  2. Time from symptom onset to hospital admission

    time between the onset of the bleeding symptoms to admission to the hospital in hours

    Measured: Baseline

  3. Time from symptom onset to andexanet alfa administration

    Time between onset of bleeding symptoms to start of the treatment with andexanet alfa in hours

    Measured: Baseline

  4. Time between last dose of FXai and andexanet alfa administration

    Time between last dose of FXai taken by the patient and the start of the treatment with andexanet alfa in hours

    Measured: Baseline

  5. Frequency that andexanet alfa is administered before or after replacement therapy;

    Number of times that a patient is treated with andexanet alfa in combination with replacement therapy

    Measured: Baseline

  6. Time interval between replacement therapy and andexanet alfa administration

    Time between treatment with andexanet alfa and replacement therapy in hours

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start6 Oct 2023
  3. Primary completion25 Nov 2025
  4. Study completion25 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05898412
Sponsor's protocol ID
D9603R00007
Status last verified
Apr 2026
First submitted
6 Apr 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Coleman CI, Dobesh PP, Danese S, Ulloa J, Lovelace B. Real-world management of oral factor Xa inhibitor-related bleeds with reversal or replacement agents including andexanet alfa and four-factor prothrombin complex concentrate: a multicenter study. Future Cardiol. 2021 Jan;17(1):127-135. doi: 10.2217/fca-2020-0073. Epub 2020 Jul 3.

    PubMed 32618210

  • Costa OS, Connolly SJ, Sharma M, Beyer-Westendorf J, Christoph MJ, Lovelace B, Coleman CI. Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis. Crit Care. 2022 Jun 16;26(1):180. doi: 10.1186/s13054-022-04043-8.

    PubMed 35710578

  • Cohen AT, Lewis M, Connor A, Connolly SJ, Yue P, Curnutte J, Alikhan R, MacCallum P, Tan J, Green L. Thirty-day mortality with andexanet alfa compared with prothrombin complex concentrate therapy for life-threatening direct oral anticoagulant-related bleeding. J Am Coll Emerg Physicians Open. 2022 Mar 5;3(2):e12655. doi: 10.1002/emp2.12655. eCollection 2022 Apr.

    PubMed 35280921

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhage, run by AstraZeneca at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient characteristics (time frame: Baseline (which is the date andexanet alfa is administered, i.e. indexdate)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05898412, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in