NCT06037200

Brief Summary

The goal of this study is to test a urine-based point-of-care testing device for direct oral anticoagulants in patients with stroke. The main questions are:

  • Can the test identify patients with direct oral anticoagulant intake?
  • Is there a time benefit of urine-based point-of-care testing compared to standard blood-based coagulation assessment?
  • Is the device feasible in the setting of acute stroke care?

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

August 30, 2023

Last Update Submit

September 13, 2023

Conditions

Stroke

Keywords

oral anticoagulationdirect oral anticoagulantspoint-of-care test

Outcome Measures

Primary Outcomes (1)

  • Time-benefit of urine-based POC-testing versus standard blood-based coagulation assessment

    i.e. difference between time delay of anti-Xa or Hemoclot testing (duration of blood sampling until result) and time delay of POC-test (duration of urine sampling until result)

    24 hours

Secondary Outcomes (3)

  • Sensitivity of POC-test

    24 hours

  • Feasibility of POC test during acute stroke care

    24 hours

  • Rate of DOAC-test within 4.5 hours

    24 hours

Other Outcomes (2)

  • Specificity

    24 hours

  • Cost-benefit of treatment of urine-based POC versus blood-based coagulation assessment

    7 days

Study Arms (2)

Patients with suspected DOAC intake

Stroke patients with safe or suspected intake of direct oral anticoagulants

Device: Urin-based test by the DOASENSE Dipstick Device

Patients without DOAC intake

Stroke patients without intake of direct oral anticoagulants

Device: Urin-based test by the DOASENSE Dipstick Device

Interventions

Urin-based test by the DOASENSE Dipstick DeviceDEVICE

Routinely assessed urine is tested by the DOASENSE Dipstick device for presence of direct oral anticoagulants. Readout is performed after 10 minutes visually and by a automated reader.

Patients with suspected DOAC intakePatients without DOAC intake

Eligibility Criteria

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

For Phase 1, approximately 40 patients are allocated to both the experimental group (i.e., stroke patients with confirmed intake of a Direct Oral Anticoagulant) and the control group (i.e., stroke patients without intake of a Direct Oral Anticoagulant). For Phase 2, consecutive patients with suspected or confirmed intake of a Direct Oral Anticoagulant, admitted to our central emergency department with a presumptive diagnosis of acute stroke, will be enrolled.

You may qualify if:

  • Patient age ≥18 years at the time of admission
  • Clinical diagnosis of ischemic or hemorrhagic stroke.
  • Treatmet at our certified stroke-unit, University Hospital Giessen.
  • Phase 1 only: Confirmed intake of a direct oral anticoagulant (DOAC) for at least 48 hours (test group) or no intake of a DOAC (control group for specificity determination)
  • Phase II only, anamnestic intake of DOAC or no information about OAC-intake.
  • Phase II only, presentation with 4.5 hours after onset.

You may not qualify if:

  • Contraindications for intravenous thrombolysis other than intake of DOAC
  • large vessel occlusion with indication for immediate endovascular thrombectomy
  • chronic renal insufficiency with need for hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University Hospital Giessen

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (4)

  • Harenberg J, Beyer-Westendorf J, Crowther M, Douxfils J, Elalamy I, Verhamme P, Bauersachs R, Hetjens S, Weiss C; Working Group Members. Accuracy of a Rapid Diagnostic Test for the Presence of Direct Oral Factor Xa or Thrombin Inhibitors in Urine-A Multicenter Trial. Thromb Haemost. 2020 Jan;120(1):132-140. doi: 10.1055/s-0039-1700545. Epub 2019 Nov 8.

    PMID: 31705521BACKGROUND

  • Siedler G, Macha K, Stoll S, Plechschmidt J, Wang R, Gerner ST, Strasser E, Schwab S, Kallmunzer B. Monitoring of direct oral anticoagulants plasma levels for secondary stroke prevention. J Thromb Haemost. 2022 May;20(5):1138-1145. doi: 10.1111/jth.15677. Epub 2022 Mar 12.

    PMID: 35171533BACKGROUND

  • Gerner ST, Huttner HB. Patients on NOACs in the Emergency Room. Curr Neurol Neurosci Rep. 2019 May 29;19(7):40. doi: 10.1007/s11910-019-0954-7.

    PMID: 31144111BACKGROUND

  • Doeppner TR, Olbricht L, Maxhuni T, Alhaj Omar O, Sachs UJ, Juenemann MB, Huttner HB, Gerner ST. Urine-based point-of-care testing for factor-Xa-inhibitors in acute ischemic stroke patients: a feasibility study. Front Neurol. 2023 Dec 15;14:1330421. doi: 10.3389/fneur.2023.1330421. eCollection 2023.

    PMID: 38162451DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Stefan Gerner, MD

    Department of Neurology, University Hospital Giessen/Germany

    PRINCIPAL INVESTIGATOR

  • Thorsten Doeppner, MD

    Department of Neurology, University Hospital Giessen/Germany

    STUDY CHAIR

  • Hagen Huttner, MD, PhD

    Department of Neurology, University Hospital Giessen/Germany

    STUDY CHAIR

Central Study Contacts

Stefan Gerner, MD

CONTACT

+49-641/985-45301stefan.gerner@neuro.med.uni-giessen.de

Thorsten Doeppner, MD

CONTACT

+49-641/985-45301thorsten.doeppner@neuro.med.uni-giessen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate professor

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 14, 2023

Study Start

January 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

DE(1)