Hemoglobin and INR Out of Nose Blood

Epistaxis Clinical Trial

Official title:

Vergleich Zwischen Hb Und INR Aus Nsaenblut Und venösem Blut

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370381
• Other study ID #: SM_16_02_2015
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: December 1, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epistaxis

Locations

Country	Name	City	State
Switzerland	Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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;42:4. doi: 10.1186/1916-0216-42-4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin in gram/liter and INR/Quick in %		During the therapy	No