Control of Epistaxis With Surgiflo

Epistaxis Clinical Trial

Official title:

Control of Epistaxis With Surgiflo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01051427
• Other study ID #: ORLEPI1
• Secondary ID: ORLEPI1
• Status: Terminated
• Phase: N/A
• First received: January 14, 2010
• Last updated: December 22, 2011
• Start date: March 2010
• Est. completion date: August 2012

Study information

• Verified date: December 2011
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis

Intervention

Device:
• Surgiflo
Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.
• Nasal catheter
In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days admitted to the hospital related to epistaxis		From intervention (nasal catheter or Surgiflo) until 1 day after discharge	No
Secondary	Discomfort and troubles related to the device used to treat epistaxis.		Within 6 months after tamponade	No