EpistaxisNCT01051427
Control of Epistaxis With Surgiflo
A study testing Surgiflo and Nasal catheter in people with Epistaxis, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using Surgiflo and if it does not work the investigators continue with a nasal catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- Surgiflo and Nasal catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2010to Aug 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with epistaxis in emergency room.
- Epistaxis does not stop with anterior nasal packing.
Who cannot join
- Pregnancy
- Allergy or intolerance to any component of Surgiflo.
- Septal perforation.
- Nasal surgery within 3 months previous to epistaxis.
- Patients admitted to hospital for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using Surgiflo and if it does not work the investigators continue with a nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose, painlessly and easily. So the investigators think it can be useful controlling nasal bleeding, so the investigators could avoid to put nasal catheters in these patients.
Read the detailed description
Epistaxis is one of the most frequent diseases in Otolaryngology emergencies. Most of them are anterior and stop with an anterior packing. Some of them does not stop with this, therefore the investigators have to put into the nose a catheter balloon. This is very painful and has many after-effects in the nose.
Surgiflo is a haemostatic matrix used for bleeding.
The investigators have design a trial to know if some people can benefit from Surgiflo instead to put a nasal catheter.
This a randomized trial with two arms. In one arm the investigators will put surgiflo and not in the other.The patient will be admitted to the hospital. The investigators will see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. The investigators will report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. To do that the investigators will make hematological tests for haemoglobin and coagulation. To know the discomfort of the device the investigators will give the patient an analog visual scale in the moment the investigators will put the device, the day after and in any of the next visits. The patient can go home again after 16h without bleeding and the investigators will see the patient again in the office after 15 days, 1, 3 and 6 months.
All the patients will receive the same analgesic protocol so the investigators can compare the discomfort.
The investigators have make statistic analysis, and they will need 24 patients for this trial. The investigators will need 2 years, approximately, to recruit them.
- Conditions
- Epistaxis
- Being tested
- Surgiflo, Nasal catheter
- Keywords
- Nasal packing, Haemostatic matrix, Epistaxis control
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgifloDevice
Also called Surgiflo haemostatic matrix.
Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.
Nasal catheterDevice
Also called Invotec, Ultra Stat, nasal catheter.
In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Nasal catheter | Active comparator | In this arm will be the patients with epistaxis that cannot be stopped with anterior nasal packing and are randomized not to put Surgiflo. So they receive the usual treatment with a nasal catheter balloon into the nose. Receives: Device: Nasal catheter |
| Surgiflo | Experimental | In this arm will be the patients with epistaxis that cannot be stopped with anterior nasal packing and are randomized to put into the nose Surgiflo. Receives: Device: Surgiflo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days admitted to the hospital related to epistaxis
Measured: From intervention (nasal catheter or Surgiflo) until 1 day after discharge
Secondary outcomes (1)
Discomfort and troubles related to the device used to treat epistaxis.
Measured: Within 6 months after tamponade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Now we use better procedures for the patient instead of nasal catheter for epistaxis. So it would be unethical to use the nasal catheter to complete the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo de los Santos, Hospital Universitario Ramon y Cajal
- Investigators
- Gonzalo de los Santos, MD, PhD, Principal investigator, Ramon y Cajal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051427
- Sponsor's protocol ID
- ORLEPI1
- Other IDs
- ORLEPI1
- Status last verified
- Dec 2011
- First submitted
- 14 Jan 2010
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mathiasen RA, Cruz RM. Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis. Laryngoscope. 2005 May;115(5):899-902. doi: 10.1097/01.MLG.0000160528.50017.3C.
PubMed 15867662Chandra RK, Conley DB, Kern RC. The effect of FloSeal on mucosal healing after endoscopic sinus surgery: a comparison with thrombin-soaked gelatin foam. Am J Rhinol. 2003 Jan-Feb;17(1):51-5.
PubMed 12693656Woodworth BA, Chandra RK, LeBenger JD, Ilie B, Schlosser RJ. A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery. Am J Otolaryngol. 2009 Jan-Feb;30(1):49-53. doi: 10.1016/j.amjoto.2007.11.008. Epub 2008 Jun 16.
PubMed 19027513Gudziol V, Mewes T, Mann WJ. Rapid Rhino: A new pneumatic nasal tamponade for posterior epistaxis. Otolaryngol Head Neck Surg. 2005 Jan;132(1):152-5. doi: 10.1016/j.otohns.2004.04.005.
PubMed 15632931
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Epistaxis With Surgiflo
- ClinicalTrials.gov ID
- NCT01051427
- Acronym / sponsor ID
- ORLEPI1
- Conditions
- Epistaxis
- Keywords
- Nasal packing, Haemostatic matrix, Epistaxis control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Now we use better procedures for the patient instead of nasal catheter for epistaxis. So it would be unethical to use the nasal catheter to complete the trial.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 18 Jan 2010 (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.
This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using Surgiflo and if it does not work the investigators continue with a nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose, painlessly and easily. So the investigators think it can be useful controlling nasal bleeding, so the investigators could avoid to put nasal catheters in these patients.
Detailed description
Epistaxis is one of the most frequent diseases in Otolaryngology emergencies. Most of them are anterior and stop with an anterior packing. Some of them does not stop with this, therefore the investigators have to put into the nose a catheter balloon. This is very painful and has many after-effects in the nose.
Surgiflo is a haemostatic matrix used for bleeding.
The investigators have design a trial to know if some people can benefit from Surgiflo instead to put a nasal catheter.
This a randomized trial with two arms. In one arm the investigators will put surgiflo and not in the other.The patient will be admitted to the hospital. The investigators will see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. The investigators will report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. To do that the investigators will make hematological tests for haemoglobin and coagulation. To know the discomfort of the device the investigators will give the patient an analog visual scale in the moment the investigators will put the device, the day after and in any of the next visits. The patient can go home again after 16h without bleeding and the investigators will see the patient again in the office after 15 days, 1, 3 and 6 months.
All the patients will receive the same analgesic protocol so the investigators can compare the discomfort.
The investigators have make statistic analysis, and they will need 24 patients for this trial. The investigators will need 2 years, approximately, to recruit them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal catheter | Active comparator | Device: Nasal catheterIn this arm will be the patients with epistaxis that cannot be stopped with anterior nasal packing and are randomized not to put Surgiflo. So they receive the usual treatment with a nasal catheter balloon into the nose. |
| Surgiflo | Experimental | Device: SurgifloIn this arm will be the patients with epistaxis that cannot be stopped with anterior nasal packing and are randomized to put into the nose Surgiflo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with epistaxis in emergency room.
- Epistaxis does not stop with anterior nasal packing.
Key exclusion criteria (5 listed)
- Pregnancy
- Allergy or intolerance to any component of Surgiflo.
- Septal perforation.
- Nasal surgery within 3 months previous to epistaxis.
- Patients admitted to hospital for other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgifloAlso: Surgiflo haemostatic matrix.Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo. | Device | Surgiflo |
| Nasal catheterAlso: Invotec, Ultra Stat, nasal catheter.In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding. | Device | Nasal catheter |
Primary outcome
Days admitted to the hospital related to epistaxis
Time frame: From intervention (nasal catheter or Surgiflo) until 1 day after discharge
1 secondary outcome
Discomfort and troubles related to the device used to treat epistaxis.
Time frame: Within 6 months after tamponade
Results and safety
The study was stopped early (reason given: Now we use better procedures for the patient instead of nasal catheter for epistaxis. So it would be unethical to use the nasal catheter to complete the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
- Background: PubMed 15867662Mathiasen RA, Cruz RM. Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis. Laryngoscope. 2005 May;115(5):899-902. doi: 10.1097/01.MLG.0000160528.50017.3C.
- Background: PubMed 12693656Chandra RK, Conley DB, Kern RC. The effect of FloSeal on mucosal healing after endoscopic sinus surgery: a comparison with thrombin-soaked gelatin foam. Am J Rhinol. 2003 Jan-Feb;17(1):51-5.
- Background: PubMed 19027513Woodworth BA, Chandra RK, LeBenger JD, Ilie B, Schlosser RJ. A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery. Am J Otolaryngol. 2009 Jan-Feb;30(1):49-53. doi: 10.1016/j.amjoto.2007.11.008. Epub 2008 Jun 16.
- Background: PubMed 15632931Gudziol V, Mewes T, Mann WJ. Rapid Rhino: A new pneumatic nasal tamponade for posterior epistaxis. Otolaryngol Head Neck Surg. 2005 Jan;132(1):152-5. doi: 10.1016/j.otohns.2004.04.005.
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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.
Gonzalo de los Santos, MD, PhD principal investigator
Ramon y Cajal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgiflo and Nasal catheter in people with Epistaxis, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Dec 2011. 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 Spain. 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 was stopped early (reason given: Now we use better procedures for the patient instead of nasal catheter for epistaxis. So it would be unethical to use the nasal catheter to complete the trial.). Results are not available in the source record.
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?
Days admitted to the hospital related to epistaxis (time frame: From intervention (nasal catheter or Surgiflo) until 1 day after discharge). 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 NCT01051427, which also lists 4 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 23 Dec 2011.