Clinical Trials Directory

Trials / Completed

CompletedNCT02370381

Hemoglobin and INR Out of Nose Blood

Vergleich Zwischen Hb Und INR Aus Nsaenblut Und venösem Blut

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
University of Zurich · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Timeline

Start date
2015-02-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2015-02-24
Last updated
2015-12-02

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02370381. Inclusion in this directory is not an endorsement.