NCT07278648

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

24 days

First QC Date

December 1, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Antithrombotic TreatmentHemorragic EventAnticoagulants

Outcome Measures

Primary Outcomes (1)

  • Hemorragic event

    Proportion of patients who experience a hemorrhagic event within 90 days of hospital discharge

    Day 90 from baseline

Study Arms (1)

Anticoagulant therapy

Patients who has been discharged from hospital with anticoagulant therapy

Other: Antithrombotic therapy

Interventions

Anticoagulant treatment prescribed at discharge from an acute care unit

Anticoagulant therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who has been discharged from an acute care unit with anticoagulant therapy

You may qualify if:

  • 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

You may not qualify if:

  • Those who are not part of the CSAPG healthcare area.
  • Patients discharged from outpatient clinics, home hospitalization units, intermediate care, or residential facilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Vilafranca

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

MeSH Terms

Conditions

Acute Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Noemí Casaponsa

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

February 5, 2026

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL
Time Frame
After publication of main results of the study.
Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations