Outcomes of patients with bleeding in the gastrointestinal tract, following treatment with Hemospray
| ISRCTN | ISRCTN29594250 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29594250 |
| Secondary identifying numbers | n/a |
- Submission date
- 20/07/2018
- Registration date
- 05/09/2018
- Last edited
- 19/04/2021
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English Summary
Background and study aims
The treatment of gastrointestinal bleeding can be challenging. Endoscopy (the use of a tube with a camera to see inside the body) into the stomach can deliver treatment of the bleeding in the form of injections, clips and heat therapy. Hemospray is a white powder that can be sprayed onto the bleeding lesion via an endoscope to stop gastrointestinal bleeding through formation of a barrier. The aim of this project was to study the effectiveness of Hemospray to treat gastrointestinal bleeding.
Who can participate?
Adults with gastrointestinal bleeding
What does the study involve?
Patients with gasrointestinal bleeding will have an endoscopy procedure where they are treated with Hemospray to treat the bleeding, either alone or in combination with injections, clips or heat therapy. Hemospray is currently part of standard care for patients with gastrointestinal bleeding, and its use is at the discretion of the endoscopy doctor. There is no direct participation in this study for patients, as this study was completed through observation of the medical records of these patients.
What are the possible benefits and risks of participating?
There are no known benefits of participation in this study, as Hemospray treatment is standard care for gastrointestinal bleeding. There are no known risks of participating in this study, and the only risk Hemospray treatment itself carries is the potential for an allergic reaction.
Where is the study run from?
University College London Hospital, UK
When is the study starting and how long is it expected to run for?
January 2016 to January 2026
Who is funding the study?
This study is not funded, as Hemospray treatment is part of patient’s standard of care and this study only involves observing the outcomes of this standard treatment
Who is the main contact?
Dr Rehan Haidry, Consultant Gastroenterologist, University College London Hospital (UCLH)
rehan.haidry@nhs.net
Contact information
Scientific
Charles Bell House, 43-45 Foley Street, London
London
W1W 7TS
United Kingdom
 ORCID ID |
0000-0001-8308-1667 |
|---|---|
| Phone | +44 (0)7723035400 |
| d.alzoubaidi@ucl.ac.uk |
Study information
| Study design | Observational prospective multi-centre international registry |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | The use of Hemospray is part of standard care of patients, therefore no participant sheet is available. |
| Scientific title | Outcomes from an international multi-centre registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray |
| Study hypothesis | Hemospray is effective in the management of gastrointestinal bleeding |
| Ethics approval(s) | Presented to the London - South East Research Ethics Committee. The outcome was that the project would more appropriately be classified and managed as service evaluation and development rather than research, therefore no ethics approval is required. |
| Condition | Gastrointestinal bleeding |
| Intervention | Participants were treated with Hemospray after endoscopic procedures as per routine clinical practice and their clinical records were observed for a 30 day period. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Endoscopic hemostasis of gastrointestinal bleeding when Hemospray is used on its own as monotherapy, dual therapy or rescue therap within 5 minutes of application of Hemospray. |
| Secondary outcome measures | The following are tracked over the 30 days of observation of hospital records: 1. Re-bleeding in less than 24 hours post initial endoscopy, at 24-72 hours, 4-7 days, 7-14 days and more than 14 days after the initial endoscopic therapy with Hemospray 2. 7 day and 30 day all-cause mortality 3. Baseline pathology and disease specific outcomes 4. Adverse events |
| Overall study start date | 01/01/2016 |
| Overall study end date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10000 |
| Participant inclusion criteria | 1. Aged 18 years or older 2. Gastrointestinal bleeding |
| Participant exclusion criteria | 1. Allergic to Hemospray 2. Known perforation |
| Recruitment start date | 26/12/2016 |
| Recruitment end date | 01/01/2026 |
Locations
Countries of recruitment
- England
- France
- Germany
- United Kingdom
- United States of America
Study participating centre
Fitzrovia
London
NW1 2BU
United Kingdom
Sponsor information
Not defined
N/A
N/A
N/A
United Kingdom
| Website | N/A |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Currently being considered for submission to Gastrointestinal Endoscopy (GIE). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from Dr Durayd Alzoubaidi (d.alzoubaidi@ucl.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/06/2017 | Yes | No | |
| Results article | 01/01/2020 | 19/04/2021 | Yes | No |
Editorial Notes
19/04/2021: Publication reference added.
09/07/2020: The trial contact details have been made publicly visible.
