High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Disease
• Intervention / Treatment: Other: Antithrombotic therapy

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 0034938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: Mar Saavedra; Phone Number: 0034938960025; Email: msaavedra@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Vilafranca del Penedès, Barcelona, Spain, 08720
      • Hospital de Vilafranca
      • Contact: Noemí Casaponsa; Phone Number: 43197 0034938960025; Email: recerca@csapg.cat
      • Contact: Mar Saavedra; Phone Number: 0034938960025; Email: msaavedra@csapg.cat
      • Principal Investigator: Mar Saavedra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anticoagulant therapy; Patients who has been discharged from hospital with anticoagulant therapy	Other: Antithrombotic therapy; Anticoagulant treatment prescribed at discharge from an acute care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemorragic event	Proportion of patients who experience a hemorrhagic event within 90 days of hospital discharge	Day 90 from baseline

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Anticoagulants; Antithrombotic Treatment; Hemorragic Event
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Acute Disease
• Other Study ID Numbers: CSAPG-79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No