Control of Epistaxis With Surgiflo

December 22, 2011 updated by: Gonzalo de los Santos, Hospital Universitario Ramon y Cajal
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Ramón y Cajal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nasal catheter
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.
Device: Nasal catheter
In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.
Other Names:
  • Invotec, Ultra Stat, nasal catheter.
Experimental: Surgiflo
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.
Device: Surgiflo
Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.
Other Names:
  • Surgiflo haemostatic matrix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days admitted to the hospital related to epistaxis
Time Frame: From intervention (nasal catheter or Surgiflo) until 1 day after discharge
From intervention (nasal catheter or Surgiflo) until 1 day after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Discomfort and troubles related to the device used to treat epistaxis.
Time Frame: Within 6 months after tamponade
Within 6 months after tamponade

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Ramon y Cajal

Investigators

  • Principal Investigator: Gonzalo de los Santos, MD, PhD, Ramón y Cajal Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

December 22, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORLEPI1 (Other Identifier: Ethical Committee of the Ramon y Cajal hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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