Hemoglobin and INR Out of Nose Blood

NCT ID: NCT02370381

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-06-30

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.

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

Epistaxis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Epistaxis

Patients with active anterior epistaxis

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Soyka, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

ORL USZ

Locations

Zurich University Hospital

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 23772329 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23663751 (View on PubMed)

Other Identifiers

SM_16_02_2015

Identifier Type: -

Identifier Source: org_study_id