Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding
HALT
Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
1 other identifier
interventional
67
4 countries
12
Brief Summary
The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
12 active sites
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
First Submitted
Initial submission to the registry
February 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2017
CompletedFebruary 5, 2018
February 1, 2018
5.4 years
February 17, 2011
February 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with further bleed
72 Hours
Secondary Outcomes (1)
Proportion of patients with initial hemostasis
At the conclusion of the index procedure
Study Arms (1)
Hemospray Treatment
EXPERIMENTALHemospray Kit
Interventions
Hemostasis of Arterial GI Bleeding
Eligibility Criteria
You may qualify if:
- Bleeding peptic ulcer
You may not qualify if:
- Patient is: \< 18 years of age
- Patient is unable to consent
- Patient is contraindicated to undergo endoscopy
- Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
- Patient is pregnant or lactating
- Patinet has an INR \> 2.5
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Royal Alexandra
Edmonton, Alberta, TSH 4B9, Canada
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Health Science Centre University of Manitoba
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
London Health Sciences Center
London, Ontario, N6A 4G5, Canada
The Ottawa Hospital- Civic Campus and General Campus
Ottawa, Ontario, K1Y 4E9, Canada
McGill University Health Center
Montreal, Quebec, H3G 1A4, Canada
Prince of Wales Hospital
Hong Kong, Hong Kong
Erasmus MC University Medical Center
Rotterdam, 3015 CE, Netherlands
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Bradford Teaching Hospital NHS Foundation
Bradford, BD96RJ, United Kingdom
University of Nottingham
Nottingham, NG 2UH, United Kingdom
Related Publications (1)
Sung JJY, Moreea S, Dhaliwal H, Moffatt DC, Ragunath K, Ponich T, Barkun AN, Kuipers EJ, Bailey R, Donnellan F, Wagner D, Sanborn K, Lau J. Use of topical mineral powder as monotherapy for treatment of active peptic ulcer bleeding. Gastrointest Endosc. 2022 Jul;96(1):28-35.e1. doi: 10.1016/j.gie.2022.01.020. Epub 2022 Feb 3.
PMID: 35124074DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2011
First Posted
March 2, 2011
Study Start
December 1, 2011
Primary Completion
April 30, 2017
Study Completion
May 29, 2017
Last Updated
February 5, 2018
Record last verified: 2018-02