Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip

NCT02537353 | Unknown Phase 4 DMC

• 1 other identifier: 14186713000000068
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Upper gastrointestinal bleeding; Hemospray; Endoscopic hemostasis

Outcome Measures

Primary Outcomes (1)

• Initail hemostasis after endoscopic hemostatic procedure

  up to 24 hours after endoscopic hemostatic procedure

Secondary Outcomes (1)

• Rebleeding rate after endoscopic hemostatic procedure

  participants will be followed for the duration of hospital stay, an expected avarage of 1 week

Study Arms (2)

Group 1

PLACEBO COMPARATOR

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. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application of metal clips. The 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.

Device: Metal clips; Procedure: Endoscopy Exam; Drug: Adrenaline

Group 2

ACTIVE COMPARATOR

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. The group will be submitted to injection of adrenaline at a proportion of 1: 10,000 in the four quadrants of the lesion associated with application adsorption powder, marketed under the name Hemospray. The 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: Hemospray; Procedure: Endoscopy Exam; Drug: Adrenaline

Interventions

Metal clips DEVICE

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

Group 1

Hemospray DRUG

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

Also known as: Dust adsorption

Group 2

Endoscopy Exam PROCEDURE

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.

Also known as: Upper Digestive Endoscopy

Group 1; Group 2

Adrenaline DRUG

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

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

hemospray; Epinephrine

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Felipe I Baracat

  Hospital das Clínicas FMUSP

  STUDY CHAIR

• Eduardo GH de Moura

  Hospital das Clínicas FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Cândido

CONTACT

55-11-26619577; ana.candido@hc.fm.usp.br

Felipe I Baracat

CONTACT

55-11-26617579; fibaracat@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 1, 2015

Record last verified: 2015-07