Control of Epistaxis With Surgiflo
|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|
- 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 ]
- Discomfort and troubles related to the device used to treat epistaxis. [ Time Frame: Within 6 months after tamponade ] [ Designated as safety issue: No ]
|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)|
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.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051427
|Ramon y Cajal Hospital|
|Madrid, Spain, 28034|
|Principal Investigator:||Gonzalo de los Santos, MD, PhD||Ramon y Cajal Hospital|