Hemoglobin and INR Out of Nose Blood

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT02370381
Collaborator
(none)
20
1
3.9
5.1

Study Details

Study Description

Brief Summary

Nose bleeding (epistaxis) is a common emergency. It is often difficult to estimate blood loss and the current hemoglobin of patients. In patients with oral anticoagulation, it is important to measure the level of hemodilution. Several situations with the importance of the fast determination of these parameters have been identified in previous studies [1,2]. The blood sampling from the venous punction is the standard in these investigations. However, this requires the corresponding painful puncture and also the time required at the laboratory.

Since many patients present themselves with active bleeding, it is obvious that this blood could be used for determining the following parameters: Hemoglobin and INR/Quick. The nose blood can be analyzed with commercial rapid test devices. If these devices could generate same or similar results and after further validation of the method, painful punctures could be waived.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with active epistaxis are verbally elucidated about the study and the verbal consent is obtained. According to the agreement a few drops of nose blood are preserved. Subsequently the standard therapy is performed. This blood sample is promptly analyzed with the rapid test devices.

    We successfully applied the exception to the analysis of blood samples prior to obtaining the written consent due to following reasons: Analysis with the rapid test devices needs to be immediate and without delay in order to satisfy quality standards prescribed by the manufacturers. In addition, patient's treatment should not be delayed.

    Simultaneously, a venous blood sample for the corresponding values is carried out according to medical indications. After the treatment of the acute emergency and thus after the greatest stress situation, we ask the patient again whether he agrees to the study conditions. The written consent is obtained in the end of the acute treatment.

    Both inception and termination of the research project will be reported within 90 days of the Ethics Committee.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Vergleich Zwischen Hb Und INR Aus Nsaenblut Und venösem Blut
    Study Start Date :
    Feb 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2015
    Actual Study Completion Date :
    Jun 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Epistaxis

    Patients with active anterior epistaxis

    Outcome Measures

    Primary Outcome Measures

    1. Hemoglobin in gram/liter and INR/Quick in % [During the therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with active nose bleeding

    • Indication for routine blood sampling

    • Aged 18 to 99 years

    • Verbal informed consent before implementation takes place

    • Written consent of the participating person after investigation and completion of treatment

    Exclusion Criteria:
    • No active bleeding

    • Routine blood sampling for medical reasons not indicated

    • Lack of understanding of the study or investigation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zurich University Hospital Zurich Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Principal Investigator: Michael Soyka, Dr. med., ORL USZ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02370381
    Other Study ID Numbers:
    • SM_16_02_2015
    First Posted:
    Feb 24, 2015
    Last Update Posted:
    Dec 2, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2015