Gastrointestinal HemorrhageNCT03611504
Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort
An observational study of Gastrointestinal Hemorrhage and Ulcer Hemorrhage, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
This is an observational, retrospective, analytical, and multicenter study conducted at 17 hospitals. Our research aims to assess the effectiveness of Hemospray® in patients with gastrointestinal bleeding in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Hemorrhage, Ulcer Hemorrhage, Tumor Bleeding
- What is being tested?
- Hemospray®
- Type of treatment
- Medical device
- How many people
- 261 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 30 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with gastrointestinal bleeding treated with Hemospray®.
Who may be able to join
- Patients with gastrointestinal bleeding treated with Hemospray®.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.
This is an observational, retrospective, analytical, and multicenter study conducted at 17 hospitals. Our research aims to assess the effectiveness of Hemospray® in patients with gastrointestinal bleeding in clinical practice. Besides, we aim to detect predictors of treatment failure defined as unsuccessful immediate hemostasis or rebleeding.
- Being tested
- Hemospray®
- Keywords
- Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemospray®Device
Also called Hemostatic powder
Hemospray® application
| Study group | Role | What they receive |
|---|---|---|
| Hemospray® group | Patients with gastrointestinal bleeding treated with Hemospray®. Receives: Device: Hemospray® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemospray® intraprocedural bleeding control
It refers to the proportion (%) of patients who achieves intraprocedural hemostasis with Hemospray®. Intraprocedural bleeding control is defined as endoscopic observation of bleeding cessation after Hemospray® use.
Measured: From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.
Rebleeding rate
To describe the rebleeding rate (%) after Hemospray®. Rebleeding is defined as a new episode of hematemesis, rectorrhagia or melena; hemoglobin level decrease >2 g/dL within 48 h of the index endoscopy or direct visualization of active bleeding at the previously treated lesion at repeat endoscopy.
Measured: Date of Hemospray® application until rebleeding, assessed up to 48 months
Secondary outcomes (2)
Adverse events potentially related to Hemospray®
Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated.
Measured: From Hemospray application until day +7
Mortality
% of patients who die after Hemospray® application
Measured: From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Jul 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca, Hospital del Mar, Puerta de Hierro University Hospital, Complejo Hospitalario de Navarra, Hospital de Henares, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Quirón Madrid University Hospital, Hospital de Cruces, Hospital General Universitario Gregorio Marañon, Hospital Universitario Central de Asturias, Hospital Universitario de Cabuenes, Hospital Universitario Doctor Peset, Hospital del Rio Hortega, Hospital Universitario Madrid Sanchinarro, Hospital de Aviles, Hospital IMQ Zorrozaurre
- Responsible party
- Principal investigator, Enrique Rodríguez de Santiago, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611504
- Sponsor's protocol ID
- HRC-HEMOSPRAY
- Status last verified
- Feb 2019
- First submitted
- 16 Jul 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study database will be available for other researches. The study protocol is already available at AEG-RedCap platform. STROBE guidelines will be followed.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.
- ClinicalTrials.gov ID
- NCT03611504
- Acronym / sponsor ID
- HRC-HEMOSPRAY
- Keywords
- Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- University of Salamanca, Hospital del Mar, Puerta de Hierro University Hospital, Complejo Hospitalario de Navarra, Hospital de Henares, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Quirón Madrid University Hospital, Hospital de Cruces, Hospital General Universitario Gregorio Marañon, Hospital Universitario Central de Asturias, Hospital Universitario de Cabuenes, Hospital Universitario Doctor Peset, Hospital del Rio Hortega, Hospital Universitario Madrid Sanchinarro, Hospital de Aviles, Hospital IMQ Zorrozaurre
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
This is an observational, retrospective, analytical, and multicenter study conducted at 17 hospitals. Our research aims to assess the effectiveness of Hemospray® in patients with gastrointestinal bleeding in clinical practice. Besides, we aim to detect predictors of treatment failure defined as unsuccessful immediate hemostasis or rebleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemospray® group | – | Device: Hemospray®Patients with gastrointestinal bleeding treated with Hemospray®. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with gastrointestinal bleeding treated with Hemospray®.
Key inclusion criteria (1 listed)
- Patients with gastrointestinal bleeding treated with Hemospray®.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Hemospray®Also: Hemostatic powderHemospray® application | Device | Hemospray® group |
Primary outcome
Hemospray® intraprocedural bleeding control
Time frame: From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.
It refers to the proportion (%) of patients who achieves intraprocedural hemostasis with Hemospray®. Intraprocedural bleeding control is defined as endoscopic observation of bleeding cessation after Hemospray® use.
Rebleeding rate
Time frame: Date of Hemospray® application until rebleeding, assessed up to 48 months
To describe the rebleeding rate (%) after Hemospray®. Rebleeding is defined as a new episode of hematemesis, rectorrhagia or melena; hemoglobin level decrease >2 g/dL within 48 h of the index endoscopy or direct visualization of active bleeding at the previously treated lesion at repeat endoscopy.
2 secondary outcomes
Adverse events potentially related to Hemospray®
Time frame: From Hemospray application until day +7
Mortality
Time frame: From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first
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 21 Feb 2019.
- Individual participant dataSharing planned: Yes. The study database will be available for other researches. The study protocol is already available at AEG-RedCap platform. STROBE guidelines will be followed.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage and Ulcer Hemorrhage, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 1 inclusion and 1 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Hemospray® intraprocedural bleeding control (time frame: From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2019.