Acute DiseaseNCT07278648
High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department
An observational study of Acute Disease, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
This observational study aims to estimate the proportion of patients discharged from a hospital with a prescription for anticoagulant medication who subsequently visit the emergency department due to an adverse thrombotic or hemorrhagic event related to the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Disease
- What is being tested?
- Antithrombotic therapy
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2027to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients who has been discharged from an acute care unit with anticoagulant therapy
Who may be able to join
- Patients discharged from the Emergency Department (ED) and acute care units with an electronic prescription for at least one anticoagulant medication (new or ongoing), identified with the following codes:
- B01AA - Vitamin K antagonists: warfarin and acenocoumarol
- B01AB - Heparin group: low-molecular weight heparins such as enoxaparin, tinzaparin, bemiparin, …
- B01AE - Direct thrombin inhibitors: dabigatran
- B01AF - Direct factor Xa inhibitors: rivaroxaban, apixaban, edoxaban
Who cannot join
- Those who are not part of the CSAPG healthcare area.
- Patients discharged from outpatient clinics, home hospitalization units, intermediate care, or residential facilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital de Vilafranca
Vilafranca del Penedès, Barcelona, 08720
Mar Saavedra, 0034938960025, msaavedra@csapg.cat
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
About this study
Official title: Prescription of High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department. Retrospective Cohort Study
This observational study aims to estimate the proportion of patients discharged from a hospital with a prescription for anticoagulant medication who subsequently visit the emergency department due to an adverse thrombotic or hemorrhagic event related to the treatment.
- Conditions
- Acute Disease
- Being tested
- Antithrombotic therapy
- Keywords
- Antithrombotic Treatment, Hemorragic Event, Anticoagulants
- Medical subject headings
- Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombotic therapyOther
Anticoagulant treatment prescribed at discharge from an acute care unit
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulant therapy | Patients who has been discharged from hospital with anticoagulant therapy Receives: Other: Antithrombotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorragic event
Proportion of patients who experience a hemorrhagic event within 90 days of hospital discharge
Measured: Day 90 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start5 Feb 2027 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278648
- Sponsor's protocol ID
- CSAPG-79
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription of High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department. Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07278648
- Acronym / sponsor ID
- CSAPG-79
- Conditions
- Acute Disease
- Keywords
- Antithrombotic Treatment, Hemorragic Event, Anticoagulants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 5 Feb 2027 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Dec 2025 (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 observational study aims to estimate the proportion of patients discharged from a hospital with a prescription for anticoagulant medication who subsequently visit the emergency department due to an adverse thrombotic or hemorrhagic event related to the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulant therapy | – | Other: Antithrombotic therapyPatients who has been discharged from hospital with anticoagulant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who has been discharged from an acute care unit with anticoagulant therapy
Key inclusion criteria (5 listed)
- Patients discharged from the Emergency Department (ED) and acute care units with an electronic prescription for at least one anticoagulant medication (new or ongoing), identified with the following codes:
- B01AA - Vitamin K antagonists: warfarin and acenocoumarol
- B01AB - Heparin group: low-molecular weight heparins such as enoxaparin, tinzaparin, bemiparin, …
- B01AE - Direct thrombin inhibitors: dabigatran
- B01AF - Direct factor Xa inhibitors: rivaroxaban, apixaban, edoxaban
Key exclusion criteria (2 listed)
- Those who are not part of the CSAPG healthcare area.
- Patients discharged from outpatient clinics, home hospitalization units, intermediate care, or residential facilities.
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 |
|---|---|---|
| Antithrombotic therapyAnticoagulant treatment prescribed at discharge from an acute care unit | Other | Anticoagulant therapy |
Primary outcome
Hemorragic event
Time frame: Day 90 from baseline
Proportion of patients who experience a hemorrhagic event within 90 days of hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
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 Acute Disease, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 5 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: opening soon, as of the sponsor's last update on 27 Oct 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mar Saavedra (0034938960025, msaavedra@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorragic event (time frame: Day 90 from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.