Gastrointestinal BleedingGRAPHENCT02595853
Efficacy of a Novel Hemostatic Powder in GI Bleeding
An observational study of Gastrointestinal Bleeding, run by Nantes University Hospital at 19 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- Non interventional study
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Oct 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
- Non Inclusion Criteria:
- Patient under guardianship, curatorship.
- Pregnant woman.
Who cannot join
None listed.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
France18 sites
Angers University Hospital
Angers, 49933
Besançon University Hospital
Besançon, 25030
Bordeuax University Hospital
Bordeaux, 33076
Lille University Hospital
Lille, 59037
Limoges University Hospital
Limoges, 87042
La Conception University Hospital
Marseille, 13005
La Timone University Hospital
Marseille, 13005
Nantes University Hospital
Nantes, 44093
Nîmes University Hospital
Nîmes, 30029
Cochin University Hospital
Paris, 75000
Georges Pompidou University Hospital (AP-HP)
Paris, 75000
Henri Mondor University Hospital (AP-HP)
Paris, 75000
Lariboisière University Hospital (AP-HP)
Paris, 75000
Rouen University Hospital
Rouen, 76031
Saint-Brieuc University Hospital
Saint-Brieuc, 22000
Clinique des Cèdres
Toulouse, 31000
Tours University Hospital
Tours, 37044
Vichy Hospital
Vichy, 03200
About this study
Official title: A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice
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.
- Conditions
- Gastrointestinal Bleeding
- Being tested
- Non interventional study
- Keywords
- Upper GastroIntestinal bleeding, endoscopy, Hemospray
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595853
- Sponsor's protocol ID
- RC14_0077
- Acronym
- GRAPHE
- Status last verified
- Sep 2021
- First submitted
- 29 Oct 2015
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27760437
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice
- ClinicalTrials.gov ID
- NCT02595853
- Acronym / sponsor ID
- GRAPHE / RC14_0077
- Conditions
- Gastrointestinal Bleeding
- Keywords
- Upper GastroIntestinal bleeding, endoscopy, Hemospray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyAll 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. | Other | – |
Primary outcome
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.
Time frame: 30 days
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques.
1 secondary outcome
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
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 27760437Haddara 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.
Related trials for Gastrointestinal Bleeding
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding, run by Nantes University Hospital at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.