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OpenTrials
Completed

NCT Number: NCT02370381

Hemoglobin and INR Out of Nose Blood

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zurich University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: During the therapy

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Vergleich Zwischen Hb Und INR Aus Nsaenblut Und venösem Blut

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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