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Epistaxis clinical trials

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NCT ID: NCT03954782 Completed - Clinical trials for Telangiectasia, Hereditary Hemorrhagic

Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease.

EPICURE
Start date: June 22, 2020
Phase: Phase 2
Study type: Interventional

The recognized manifestations of HHT are all due to abnormalities in vascular structure. Epistaxis are spontaneous, very variable, may occur as often as several times every day, and are recurrent in 90% of patients and associated with chronic and severe anemia in 2-10%. They also significantly reduce quality of life. Blood transfusions are sometimes required in 10-30% of patients. Previous studies showed that antiangiogenic treatments such as anti-VEGF treatment (bevacizumab) administered intravenously was efficient on epistaxis and dramatically reduced nosebleeds. Tyrosine kinase inhibitors are anti-angiogenic molecules which are available orally and could therefore overcome the difficulties encountered with bevacizumab. The investigator hypothesized that nintedanib, acting by indirect inhibition of the VEGF receptor should allow a reduction of epistaxis in HHT patient. Nintedanib has been used in one HHT patient following the diagnosis of Insterstitial Pulmonary Fibrosis (published case report in 2017, Kovacs et al) with encouraging results. The aim is to evaluate efficacy of nintedanib for the treatment of epistaxis in HHT patients

NCT ID: NCT03912051 Completed - Epistaxis Clinical Trials

Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting

BATSI
Start date: March 27, 2019
Phase: N/A
Study type: Interventional

Between 10 and 12% of the general population suffers from epistaxis, out of which 10% would need to be medically managed. Most of patients treated for epistaxis are managed through emergency departments. The involvement of the ENT (ear, nose and throat) surgeon might be required in more complex situations in order to control bleeding. Usually, nasal packing packing is used as a first line option after failure of digital compression. Epistaxis balloons are often used after failure of nasal packing Balloons are effective in approximately 60% of the patients with a rapid control of bleeding by compression followed by an absence of rebreeding after balloon removal. The main challenges for patients treated with this device are i) pain upon balloon introduction and inflation ii) discomfort upon introduction in the nasal cavity as well as during balloon maintenance during 24 to 72 hours of tamponade iii) blood retention between distal and proximal balloons that favors infection iv) limited breathing capabilities through the nostrils which increases general discomfort v) negative aesthetic impact for the patient vi) septal and alar necrosis risk in case of prolonged compression. Moreover, epistaxis leading to an hospitalization between 24 to 48h are not rare (>11 000 in France in 2017 according to ATIH). Those hospitalizations are often decided in order to ensure an optimal patient monitoring following packing or epistaxis balloon placement. In order to address those adverse events while keeping the same efficacy and avoiding hospitalizations or reducing their duration, the use of an asymmetric, more physiological, easy to use and mainly intranasal (discreet proximal extremity) is studied.

NCT ID: NCT03850964 Recruiting - Anemia Clinical Trials

Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz)

Paz
Start date: May 8, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

During the Efficacy Study (Part B), the investigators will study whether Pazopanib, taken daily for 24 weeks, will reduce the severity of nose bleeds in patients with hereditary hemorrhagic telangiectasia (HHT). Patients will either be provided active drug or a placebo [sugar - inactive pill], and be tested for nose bleed severity throughout the trial, including particularly nose bleed duration. Investigators will also test for blood loss, as well as for safety. This study is funded by the US Department of Defense USAMRAA and FDA/OOPD.

NCT ID: NCT03850730 Not yet recruiting - Epistaxis Clinical Trials

Pazopanib for the Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia

Start date: July 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Investigators will test the value of very low dose Pazopanib administered to patients with hereditary hemorrhagic telangiectasia for the reduction in the severity of nose bleeds in those with frequent and long duration bleeding episodes.

NCT ID: NCT03788460 Not yet recruiting - Epistaxis Clinical Trials

Correlation Between PT and INR to Factor 7

Start date: January 7, 2019
Phase:
Study type: Observational

The purpose of our study: Given the large number of coagulability tests done before a number of surgeries, specially otolaryngology procedures, such as tonsillectomy and adenoidectomy, as well as a part of epistaxis workup, prothrombin time (PT) and partial thromboplastin time (PTT) were checked, and it was found that in some people there is an isolated elongated PT, a low level of factor VII was found in these people. The purpose of the current study is to find a correlation between the value of PT\INR and the level of factor VII, we tried to do so by a retro-prospective study on patients known to have a factor VII deficiency at Laniado hospital, such a correlation could make both the diagnosis and the management of people with factor VII deficiency easier and more accessible. The study levels: 1. Data collection : On the children's population who are known for their lack of Factor VII, we will check PT levels, we will concentrate the data in the table, along with personal information such as age and gender 2. Data Processing : We will try to conduct a statistical relationship between the PT values and Factor VII levels, to look for statistical significance, we will try to find a model for predicting the level of factor VII based on PT Number of participants: 60 participants Ages of participants: 0-18 years old Gender of participants: Both sexes Inclusion criteria: 1. A participant who is 0-18 years old 2. A participant who is, except for bleeding tendency, healthy in general 3. A participant who has elongated PT 4. A participant who has normal PTT Exclusion criteria: 1. Background disease 2. Use of medications 3. Use of anti coagulation drugs The duration of the study : The study is of a retrospective type, we already have a number of subjects, we need more as to reach statistical significance, so the expectation is two to three months

NCT ID: NCT03740620 Completed - Clinical trials for Intubation Complication

The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.

NCT ID: NCT03678168 Completed - Pain Clinical Trials

A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology surgeries due to the use of throat packs during the procedure. In order to optimize quality of care and patient satisfaction, the aim of this study to evaluate the incidence of post-operative, throat pain, nausea and vomiting in patients that have been packed with either conventional gauze throat packs or pharyngeal tampons.

NCT ID: NCT03360045 Completed - Epistaxis Clinical Trials

Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis

Start date: May 1, 2018
Phase: Phase 4
Study type: Interventional

Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing. In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Three different therapy option are created; first, nasal compression with tranexamic acid, second, simple nasal compression without any drugs. And third, packing with Merocel.

NCT ID: NCT03152019 Completed - Clinical trials for Hemorrhagic Hereditary Telangiectasia (HHT)

Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hemorrhagic Hereditary Telangiectasia (HHT)

TACRO
Start date: May 22, 2017
Phase: Phase 2
Study type: Interventional

The recognized manifestations of HHT are all due to abnormalities in vascular structure. Epistaxis due to telangiectases formation is spontaneous, very variable, recurrent in 90% of patients, and associated with severe anemia in 2-10%. They also significantly reduce quality of life. Improvement in epistaxis has been shown in HHT patients after a liver transplantation. It was hypothesized that the immunosuppressive treatment (FK506) used to prevent rejection may have an anti-angiogenic effect. The results of Albiñana et al suggest that the mechanism of action of FK506 involves a partial correction of endoglin and ALK1 haplosufficiency, genes responsible for 90% of HHT case. Tacrolimus ointment is available on the market for the treatment of eczema and can therefore readily be used as it is for nasal administration. Topical nasal administration of tacrolimus may be an easy local ENT treatment that is non-aggressive and results in little trauma for the patient in relation to other first line treatment possibilities. The main objective of this trial is to evaluate, at 6 weeks after the end of the treatment, the efficacy on the duration of nosebleeds, of 6 weeks tacrolimus nasal ointment application, in patients with HHT complicated by nosebleeds (30 min/6 weeks). Secondary objectives are to evaluate the tolerance throughout the study, the efficacy on anemia and on clinical parameters (nosebleeds, quality of life, epistaxis severity score questionnaire and blood transfusions) and the systemic absorption of nasal administration. This is a multicenter prospective and double blinded phase I/II trial. A total of 48 patients will be randomized versus placebo using an allocation ratio of 1:1. The ointment (Protopic® at 0.1% or placebo) will be self-administered by the patient with one administration in each nostril twice a day for 6 consecutive weeks.

NCT ID: NCT03092973 Completed - Atherosclerosis Clinical Trials

Carotid Intima Media Thickness (CIMT) in Epistaxis

Start date: December 1, 2016
Phase: N/A
Study type: Observational

Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined the carotid intima media thickness via ultrasound in patients who were treated in the ENT-department of the University Hospital of Zurich.