Control of Epistaxis With Surgiflo

Not Applicable

Terminated

• Conditions: Epistaxis

• Registration Number: NCT01051427
• Lead Sponsor: Hospital Universitario Ramon y Cajal

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.

Study Timeline

• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23
• Primary Completion: 2012-03
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days admitted to the hospital related to epistaxis	From intervention (nasal catheter or Surgiflo) until 1 day after discharge

Secondary Outcome Measures

Name	Time	Method
Discomfort and troubles related to the device used to treat epistaxis.	Within 6 months after tamponade

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain