search
Back to results

Control of Epistaxis With Surgiflo

Primary Purpose

Epistaxis

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Surgiflo
Nasal catheter
Sponsored by
Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring Nasal packing, Haemostatic matrix, Epistaxis control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with epistaxis in emergency room.
  • Epistaxis does not stop with anterior nasal packing.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ramon y Cajal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nasal catheter

Surgiflo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Days admitted to the hospital related to epistaxis

Secondary Outcome Measures

Discomfort and troubles related to the device used to treat epistaxis.

Full Information

First Posted
January 14, 2010
Last Updated
December 22, 2011
Sponsor
Hospital Universitario Ramon y Cajal
search

1. Study Identification

Unique Protocol Identification Number
NCT01051427
Brief Title
Control of Epistaxis With Surgiflo
Official Title
Control of Epistaxis With Surgiflo
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Ramon y Cajal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
Nasal packing, Haemostatic matrix, Epistaxis control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgiflo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Surgiflo
Other Intervention Name(s)
Surgiflo haemostatic matrix.
Intervention Description
Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.
Intervention Type
Device
Intervention Name(s)
Nasal catheter
Other Intervention Name(s)
Invotec, Ultra Stat, nasal catheter.
Intervention Description
In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.
Primary Outcome Measure Information:
Title
Days admitted to the hospital related to epistaxis
Time Frame
From intervention (nasal catheter or Surgiflo) until 1 day after discharge
Secondary Outcome Measure Information:
Title
Discomfort and troubles related to the device used to treat epistaxis.
Time Frame
Within 6 months after tamponade

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with epistaxis in emergency room. Epistaxis does not stop with anterior nasal packing. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo de los Santos, MD, PhD
Organizational Affiliation
Ramon y Cajal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramon y Cajal Hospital
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15867662
Citation
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.
Results Reference
background
PubMed Identifier
12693656
Citation
Chandra 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.
Results Reference
background
PubMed Identifier
19027513
Citation
Woodworth 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.
Results Reference
background
PubMed Identifier
15632931
Citation
Gudziol 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.
Results Reference
background

Learn more about this trial

Control of Epistaxis With Surgiflo

We'll reach out to this number within 24 hrs