Anticoagulant-related Major BleedNCT05548777
Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
An observational study of Anticoagulant-related Major Bleed, run by AstraZeneca at 1 site in United States.
Trial summary
This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Anticoagulant-related Major Bleed
- What is being tested?
- Andexanet alfa and 4F-PCC
- How many people
- 5,480 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 20 Dec 2022
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed
Who may be able to join
- ICD-10-CM diagnosis code of D68.32 (Hemorrhagic disorder due to extrinsic circulating anticoagulants) as part of an inpatient admission
- Taking either an oral FXa inhibitor or enoxaparin at the time of hospitalization for their bleeding event
- Treated with either andexanet alfa or 4F-PCC during the hospitalization for their bleeding event
- Had documented discharge disposition
Who cannot join
- Less than 18 years old
- Treated with both andexanet alfa and 4F-PCC during the hospitalization for their bleeding event
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.
Read the detailed description
This observational study will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed. Data will be collected via an audit of electronic medical charts. The primary objectives are to describe the patients' characteristics, treatments and outcomes, including length of stay and in-hospital mortality. Secondary objectives include subgroup analyses, including by bleed location. Potential differences between patients treated with andexanet alfa versus 4F-PCC, and potential differences in patient characteristics over time, will be assessed. If this assessment confirms that treatment groups can be adequately balanced and that patient characteristics have not substantially changed over time (i.e. no channeling bias is observed), the risk of in-hospital mortality with andexanet alfa versus 4F-PCC will be assessed in a comparative effectiveness analysis. If treatment groups cannot be balanced or clear signs of channelling bias are observed, the comparative analyses will be considered unfeasible and will not be performed.
- Conditions
- Anticoagulant-related Major Bleed
- Being tested
- Andexanet alfa, 4F-PCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andexanet alfaDrug
Andexanet alfa
4F-PCCDrug
Four-Factor Prothrombin Complex Concentrate (4F-PCC)
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for an anticoagulation-related major bleed | Not described Receives: Drug: Andexanet alfa; Drug: 4F-PCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
Measured: During hospitalisation, approximately 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start15 Sep 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anticoagulant-related Major BleedStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Outcomes Insights
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548777
- Sponsor's protocol ID
- D9603R00004
- Status last verified
- Nov 2023
- First submitted
- 26 Aug 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AstraZeneca disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AstraZeneca will accept request for IPD, but this does not mean requests will be granted and data shared.
Publications
Dobesh PP, Coleman CI, Danese M, Lesen E, Chang RC, Odelade O, Fermann GJ. Management of factor Xa inhibitor-related traumatic non-intracranial bleeding events with andexanet alfa or four-factor prothrombin complex concentrate in a US multicenter observational study. J Am Coll Emerg Physicians Open. 2024 Nov 7;5(6):e13333. doi: 10.1002/emp2.13333. eCollection 2024 Dec.
PubMed 39524040Dobesh PP, Fermann GJ, Christoph MJ, Koch B, Lesen E, Chen H, Lovelace B, Dettling T, Danese M, Ulloa J, Danese S, Coleman CI. Lower mortality with andexanet alfa vs 4-factor prothrombin complex concentrate for factor Xa inhibitor-related major bleeding in a U.S. hospital-based observational study. Res Pract Thromb Haemost. 2023 Aug 30;7(6):102192. doi: 10.1016/j.rpth.2023.102192. eCollection 2023 Aug.
PubMed 37753225
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
- ClinicalTrials.gov ID
- NCT05548777
- Acronym / sponsor ID
- D9603R00004
- Conditions
- Anticoagulant-related Major Bleed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,480 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Outcomes Insights
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.
Detailed description
This observational study will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed. Data will be collected via an audit of electronic medical charts. The primary objectives are to describe the patients' characteristics, treatments and outcomes, including length of stay and in-hospital mortality. Secondary objectives include subgroup analyses, including by bleed location. Potential differences between patients treated with andexanet alfa versus 4F-PCC, and potential differences in patient characteristics over time, will be assessed. If this assessment confirms that treatment groups can be adequately balanced and that patient characteristics have not substantially changed over time (i.e. no channeling bias is observed), the risk of in-hospital mortality with andexanet alfa versus 4F-PCC will be assessed in a comparative effectiveness analysis. If treatment groups cannot be balanced or clear signs of channelling bias are observed, the comparative analyses will be considered unfeasible and will not be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for an anticoagulation-related major bleed | – | Drug: Andexanet alfa, Drug: 4F-PCC |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed
Key inclusion criteria (4 listed)
- ICD-10-CM diagnosis code of D68.32 (Hemorrhagic disorder due to extrinsic circulating anticoagulants) as part of an inpatient admission
- Taking either an oral FXa inhibitor or enoxaparin at the time of hospitalization for their bleeding event
- Treated with either andexanet alfa or 4F-PCC during the hospitalization for their bleeding event
- Had documented discharge disposition
Key exclusion criteria (2 listed)
- Less than 18 years old
- Treated with both andexanet alfa and 4F-PCC during the hospitalization for their bleeding event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andexanet alfaAndexanet alfa | Drug | Patients hospitalized for an anticoagulation-related major bleed |
| 4F-PCCFour-Factor Prothrombin Complex Concentrate (4F-PCC) | Drug | Patients hospitalized for an anticoagulation-related major bleed |
Primary outcome
Mortality
Time frame: During hospitalisation, approximately 6 days
In-hospital mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39524040Dobesh PP, Coleman CI, Danese M, Lesen E, Chang RC, Odelade O, Fermann GJ. Management of factor Xa inhibitor-related traumatic non-intracranial bleeding events with andexanet alfa or four-factor prothrombin complex concentrate in a US multicenter observational study. J Am Coll Emerg Physicians Open. 2024 Nov 7;5(6):e13333. doi: 10.1002/emp2.13333. eCollection 2024 Dec.
- Derived from this study: PubMed 37753225Dobesh PP, Fermann GJ, Christoph MJ, Koch B, Lesen E, Chen H, Lovelace B, Dettling T, Danese M, Ulloa J, Danese S, Coleman CI. Lower mortality with andexanet alfa vs 4-factor prothrombin complex concentrate for factor Xa inhibitor-related major bleeding in a U.S. hospital-based observational study. Res Pract Thromb Haemost. 2023 Aug 30;7(6):102192. doi: 10.1016/j.rpth.2023.102192. eCollection 2023 Aug.
- Redacted CSR synopsis\_D9603R00004Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AstraZeneca disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AstraZeneca will accept request for IPD, but this does not mean requests will be granted and data shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulant-related Major Bleed, run by AstraZeneca at 1 site in United States.
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 4 inclusion and 2 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 28 Nov 2023. 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 United States. 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?
Mortality (time frame: During hospitalisation, approximately 6 days). 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 NCT05548777, which also lists 2 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 28 Nov 2023.