Control of Epistaxis With Surgiflo

This study has been terminated.
(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.)
Sponsor:
Information provided by (Responsible Party):
Gonzalo de los Santos, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01051427
First received: January 14, 2010
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Epistaxis
Device: Surgiflo
Device: Nasal catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Control of Epistaxis With Surgiflo

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Days admitted to the hospital related to epistaxis [ Time Frame: From intervention (nasal catheter or Surgiflo) until 1 day after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discomfort and troubles related to the device used to treat epistaxis. [ Time Frame: Within 6 months after tamponade ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: March 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Surgiflo haemostatic matrix.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051427

Locations
Spain
Ramon y Cajal Hospital
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Investigators
Principal Investigator: Gonzalo de los Santos, MD, PhD Ramon y Cajal Hospital
  More Information

Publications:
Responsible Party: Gonzalo de los Santos, MD, PhD, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01051427     History of Changes
Other Study ID Numbers: ORLEPI1, ORLEPI1
Study First Received: January 14, 2010
Last Updated: December 22, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario Ramon y Cajal:
Nasal packing
Haemostatic matrix
Epistaxis control

Additional relevant MeSH terms:
Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014