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CompletedNCT02370381Updated Dec 2, 2015

Hemoglobin and INR Out of Nose Blood

An observational study in Epistaxis, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 99 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Epistaxis

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03

In context

Epistaxis

91 studies on the registry are indexed under Epistaxis; 20 are open to participants now.

This study's enrollment of 20 is below the median of 82 across 13 observational studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Potential candidates with active epistaxis are recruited consecutively at the Polyclinic.

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

Exclusion Criteria:

  • No active bleeding
  • Routine blood sampling for medical reasons not indicated
  • Lack of understanding of the study or investigation
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Epistaxis

    Patients with active anterior epistaxis

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What researchers measure

Primary outcomes

  1. Hemoglobin in gram/liter and INR/Quick in %

    Time frame: During the therapy

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Study locations

1 site
  • Zurich University Hospital
    Zurich, 8091, Switzerland
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References and documents

Publications

  • Soyka MB, Holzmann D. Should we test the prothrombin time in anticoagulated epistaxis patients? Allergy Rhinol (Providence). 2013 Spring;4(1):e52-3. doi: 10.2500/ar.2013.4.0049. PubMed 23772329 ↗
  • Murer K, Ahmad N, Roth BA, Holzmann D, Soyka MB. THREAT helps to identify epistaxis patients requiring blood transfusions. J Otolaryngol Head Neck Surg. 2013 Jan 31;42(1):4. doi: 10.1186/1916-0216-42-4. PubMed 23663751 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02370381
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Feb 24, 2015
Start date
Feb 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Dec 2, 2015

Study contacts

Michael Soyka, Dr. med.
principal investigator · ORL USZ

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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