Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537353
Recruitment Status : Unknown
Verified July 2015 by University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Device: Metal clips Drug: Hemospray Procedure: Endoscopy Exam Drug: Adrenaline Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Prospective, Randomized Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip Plus Epinephrine Injection in Nonvariceal Upper Gastrointestinal Bleeding
Study Start Date : September 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine

Arm Intervention/treatment
Placebo Comparator: Group 1
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
The group will be shot of adrenaline 1: 10,000 in four quadrants, associated with application of metal clips.

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.
Other Name: Upper Digestive Endoscopy

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

Active Comparator: Group 2
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
The group will be shot of adrenaline 1: 10,000 in the four quadrants associated with application adsorption powder, marketed under the name Hemospray.
Other Name: Dust adsorption

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.
Other Name: Upper Digestive Endoscopy

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




Primary Outcome Measures :
  1. Initail hemostasis after endoscopic hemostatic procedure [ Time Frame: up to 24 hours after endoscopic hemostatic procedure ]

Secondary Outcome Measures :
  1. Rebleeding rate after endoscopic hemostatic procedure [ Time Frame: participants will be followed for the duration of hospital stay, an expected avarage of 1 week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537353


Contacts
Layout table for location contacts
Contact: Ana C Cândido 55-11-26619577 ana.candido@hc.fm.usp.br
Contact: Felipe I Baracat 55-11-26617579 fibaracat@hotmail.com

Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Study Chair: Felipe I Baracat Hospital das Clínicas FMUSP
Principal Investigator: Eduardo GH de Moura Hospital das Clínicas FMUSP
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02537353    
Other Study ID Numbers: 14186713000000068
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: July 2015
Keywords provided by University of Sao Paulo General Hospital:
Upper gastrointestinal bleeding
Hemospray
Endoscopic hemostasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents