Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Prospective, Randomized Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip Plus Epinephrine Injection in Nonvariceal Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02537353
• Other study ID #: 14186713000000068
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 4, 2015
• Last updated: August 31, 2015
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2015
• Source: University of Sao Paulo General Hospital
• Contact: Ana C Cândido
• Phone: 55-11-26619577
• Email: ana.candido[@]hc.fm.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding located proximal to the angle of Treitz, whose cause is not related to esophagogastric varices or gastropathy of portal hypertension.

Animal studies showed no absorption in the GIT and disposal within 48 hours of application, and no reported cases of obstruction. Recently, a prospective study involving 20 patients with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without any complication.

Description:

The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding located proximal to the angle of Treitz, whose cause is not related to esophagogastric varices or gastropathy of portal hypertension.

Despite all therapeutic guidelines and innovations introduced in recent decades, the incidence varies between 50 and 160 cases/100000 inhabitants / year and recent data show a mortality rate of approximately 10% in hospitalized patients. In the United States the upper gastrointestinal bleeding (HDA) promotes 300,000 hospitalizations per year.

The etiologies of non-variceal, HDA remains virtually unchanged over the past 20 years, peptic ulcer disease accounts for 40-50% of cases. Other less common causes are vascular ectasia, Mallory-Weiss lacerations, acute gastroduodenal mucosal lesions, Dieulafoy lesions, tumors and other rarer.

The HDA is manifested most often by hematemesis and / or melena. In a smaller proportion of patients can only be observed a drop in hemoglobin levels, and hemodynamic instability possible, without externalization of blood. There is also a smaller chance of rectal bleeding occur, which should indicate a bleeding of major consequence.

The management of patients with HDA should be systematized and as early as possible. Due to the unpredictability of the evolution of bleeding, all patients should be kept in the hospital environment and in the presence of hemodynamic and / or comorbidities should be considered high risk instability.

Hemodynamic stabilization is the initial step in the management of patients with HDA. Recent studies show that early and intensive resuscitation measures result in decreased length of hospitalization and mortality.

Following the hemodynamic maintenance, you should evaluate the presence of active bleeding, because when present, besides translating more severe, requiring a more rapid therapeutic intervention.

There are some findings predictive of severity of bleeding that can be evaluated from a clinical standpoint, they are: hemodynamic instability, need for continued transfusion, hematemesis with "fresh blood", rectal bleeding, bleeding that began during hospitalization, rebleeding during hospitalization in patients older than 60 years and presence of comorbidities.

Endoscopy (EDA) is the test of choice for the initial evaluation of bleeding of the upper digestive tract. The goals of endoscopic examination is to recognize the point of bleeding, hemostasis proceed when indicated and recognize stigma that suggest impending rebleeding. In peptic ulcers, using the classification of Forrest, the following findings are relevant: active arterial bleeding, visible vessel, and adherent clot. The risk of rebleeding these three groups without endoscopic treatment is estimated at 90%, 50% and 25%, respectively.

Endoscopic treatment has modified the natural evolution of non-variceal upper gastrointestinal bleeding. Several studies have shown that performing endoscopic therapy significantly reduces the risk of rebleeding and the length of hospital stay, need for surgical intervention and mortality.

Are risk factors for rebleeding: chronic renal failure, liver cirrhosis, low hemoglobin levels, the need for high doses of epinephrine for hemostasis and inexperienced endoscopist.

Endoscopic techniques in the treatment of existing HDA can be divided into three major groups: injection methods, thermal and mechanical.

In several clinical trials using two methods therapy (combination therapy) was more effective than using only one method.

The injection method is the use of sclerosing substances in the four quadrants of the lesion. The mechanism of action of hemostasis associated with the local tamponade, vasoconstriction and platelet aggregation. Among the available solutions for injection can be mentioned: adrenaline, ethanolamine, polidocanol, absolute ethanol and sodium chloride.

In the thermal heat production method causes protein denaturation tissue, collagen shrinkage and therefore obstruction of the vessel perivascular contraction. Thermal methods are used: Mono and bipolar electrocoagulation, argon plasma, laser and heater probe.

The treatment with mechanical methods has been developed in recent decades with the improvement of the devices used. In endoscopic practice who have proved effective are endoclipes and ligation.

The endoclip when compared to isolated therapeutic injection of adrenaline was superior in reducing rebleeding in peptic ulcers.

In a recent study, the use of argon plasma endoclip in ulcers with active bleeding were compared. The result demonstrated efficacy in both methods, no significant difference estastistica.

A new method developed for use in upper gastrointestinal bleeding and that proved to be safe and effective in clinical trials already done is dust adsorption (Hemospray ®). This new technology consists of a syringe containing the Hemospray ® powder, inorganic property comprises a group of minerals, highly adsorptive when in contact with blood, it becomes a cohesive powder and form a stable mechanical cap that covers the bleeding site. The powder is sprayed by means of a catheter connected to a container of carbon dioxide. The catheter tip should be positioned 1-2 cm from the site of bleeding and then short bursts of 1 to 2 seconds should be fired to stop the bleeding.

Studies in animals showed no absorption in the GIT and elimination within 48 hours of application, and no reported cases of obstruction. Recently, a prospective study involving 20 patients with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without any complication.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary.

Exclusion Criteria:

• Pregnancy and History of endoscopic haemostatic procedure in the previous seven days

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Device:
• Metal clips
The group will be shot of adrenaline 1: 10,000 in four quadrants, associated with application of metal clips.

Drug:
• Hemospray
The group will be shot of adrenaline 1: 10,000 in the four quadrants associated with application adsorption powder, marketed under the name Hemospray.

Procedure:
• Endoscopy Exam
All patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.

Drug:
• Adrenaline
The injection of adrenaline solution with 50% glucose at a proportion of 1: 10000 in four quadrants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initail hemostasis after endoscopic hemostatic procedure		up to 24 hours after endoscopic hemostatic procedure	Yes
Secondary	Rebleeding rate after endoscopic hemostatic procedure		participants will be followed for the duration of hospital stay, an expected avarage of 1 week	Yes