NCT01051427

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

January 14, 2010

Last Update Submit

December 22, 2011

Conditions

Epistaxis

Keywords

Nasal packingHaemostatic matrixEpistaxis control

Outcome Measures

Primary Outcomes (1)

  • Days admitted to the hospital related to epistaxis

    From intervention (nasal catheter or Surgiflo) until 1 day after discharge

Secondary Outcomes (1)

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

    Within 6 months after tamponade

Study Arms (2)

Nasal catheter

ACTIVE COMPARATOR

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

Surgiflo

EXPERIMENTAL

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

Interventions

SurgifloDEVICE

Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.

Also known as: Surgiflo haemostatic matrix.
Surgiflo
Nasal catheterDEVICE

In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.

Also known as: Invotec, Ultra Stat, nasal catheter.
Nasal catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramon y Cajal Hospital

Madrid, Madrid, 28034, Spain

Location

Related Publications (4)

  • 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.

    PMID: 15867662BACKGROUND

  • 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.

    PMID: 12693656BACKGROUND

  • 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.

    PMID: 19027513BACKGROUND

  • 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.

    PMID: 15632931BACKGROUND

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Gonzalo de los Santos, MD, PhD

    Ramon y Cajal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 18, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

ES(1)