EpistaxisNCT02370381
Hemoglobin and INR Out of Nose Blood
An observational study of Epistaxis, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Epistaxis
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential candidates with active epistaxis are recruited consecutively at the Polyclinic.
Who may be able to join
- 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
Who cannot join
- No active bleeding
- Routine blood sampling for medical reasons not indicated
- Lack of understanding of the study or investigation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University Hospital
Zurich, Canton of Zurich, 8091
About this study
Official title: Vergleich Zwischen Hb Und INR Aus Nsaenblut Und venösem Blut
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.
- Conditions
- Epistaxis
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epistaxis | Patients with active anterior epistaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin in gram/liter and INR/Quick in %
Measured: During the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Soyka, Dr. med., Principal investigator, ORL USZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370381
- Sponsor's protocol ID
- SM_16_02_2015
- Status last verified
- Dec 2015
- First submitted
- 17 Feb 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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 23772329Murer 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vergleich Zwischen Hb Und INR Aus Nsaenblut Und venösem Blut
- ClinicalTrials.gov ID
- NCT02370381
- Acronym / sponsor ID
- SM_16_02_2015
- Conditions
- Epistaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epistaxis | – | –Patients with active anterior epistaxis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential candidates with active epistaxis are recruited consecutively at the Polyclinic.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- No active bleeding
- Routine blood sampling for medical reasons not indicated
- Lack of understanding of the study or investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin in gram/liter and INR/Quick in %
Time frame: During the therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 23772329Soyka 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.
- Background: PubMed 23663751Murer 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.
Related trials for Epistaxis
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RecruitingPhase 3
RADA16 for Adult Tonsillectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Soyka, Dr. med. principal investigator
ORL USZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epistaxis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin in gram/liter and INR/Quick in % (time frame: During the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.