NCT02595853

Brief Summary

Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

October 29, 2015

Last Update Submit

September 8, 2021

Conditions

Gastrointestinal Bleeding

Keywords

Upper GastroIntestinal bleeding, endoscopy, Hemospray

Outcome Measures

Primary Outcomes (1)

  • Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

    Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.

    30 days

Secondary Outcomes (1)

  • Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena

    30 days

Interventions

Non interventional studyOTHER

All upper gastro-intestinal bleeding need endoscopic hemostasis. Endoscopic hemostasis conventional methods are injection of saline with epinephrine, placement of hemoclips and thermic or plasma coagulation. Hemospray™ will be sprayed onto bleeding lesions seen in endoscopy after failure of conventional methods or in salvage therapy at the discretion of endoscopists. Retrospective analysis of prospectively cellected data.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients who received hemostatic powder for upper GI bleeding will be included in the study. Pregnant and adult under guardianship will be excluded.

You may qualify if:

  • Male or female aged 18 and over who need the use of Hemospray® under their care in an emergency.
  • Upper gastrointestinal hemorrhage.
  • Patients who received the information note of the study and agreeing to participate (non-oral opposition gathered in the patient's medical record)
  • Patient under guardianship, curatorship.
  • Pregnant woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Angers University Hospital

Angers, 49933, France

Location

Besançon University Hospital

Besançon, 25030, France

Location

Bordeuax University Hospital

Bordeaux, 33076, France

Location

Lille University Hospital

Lille, 59037, France

Location

Limoges University Hospital

Limoges, 87042, France

Location

La Conception University Hospital

Marseille, 13005, France

Location

La Timone University Hospital

Marseille, 13005, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Nîmes University Hospital

Nîmes, 30029, France

Location

Cochin University Hospital

Paris, 75000, France

Location

Georges Pompidou University Hospital (AP-HP)

Paris, 75000, France

Location

Henri Mondor University Hospital (AP-HP)

Paris, 75000, France

Location

Lariboisière University Hospital (AP-HP)

Paris, 75000, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Saint-Brieuc University Hospital

Saint-Brieuc, 22000, France

Location

Clinique des Cèdres

Toulouse, 31000, France

Location

Tours University Hospital

Tours, 37044, France

Location

Vichy Hospital

Vichy, 03200, France

Location

Monaco University Hospital

Monaco, 98012, Monaco

Location

Related Publications (1)

  • Haddara S, Jacques J, Lecleire S, Branche J, Leblanc S, Le Baleur Y, Privat J, Heyries L, Bichard P, Granval P, Chaput U, Koch S, Levy J, Godart B, Charachon A, Bourgaux JF, Metivier-Cesbron E, Chabrun E, Quentin V, Perrot B, Vanbiervliet G, Coron E. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry). Endoscopy. 2016 Dec;48(12):1084-1095. doi: 10.1055/s-0042-116148. Epub 2016 Oct 19.

    PMID: 27760437DERIVED

Related Links

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 4, 2015

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

FR(18)MO(1)