Hemostasis of Active GI Luminal Tract Bleeding (HALT)(study # 10-017)
Research type
Research Study
Full title
Hemostasis of Active GI Luminal Tract Bleeding (HALT)(study # 10-017)
IRAS ID
130082
Contact name
Sulleman Moreea
Contact email
Sponsor organisation
William Cook Europe ApS
Clinicaltrials.gov Identifier
Research summary
Duodenal and gastric ulcers (termed peptic ulcers) are common occurences. Bleeding from these ulcers is one of the commonest reasons for admission to hospital causing significant clinical and economic burden and resulting in 17,000-20,000 hospital admissions per year in the UK. In the last two decades there have been major advances in the clinical and endoscopic management of peptic ulcer bleeding. However, mortality remains high at around 10%, particularly in the elderly and in those with significant other diseases. The National Institute for Clinical Excellence (NICE) has issued guidance on the management of peptic ulcer bleeds and recommend the early use of endoscopy (an instrument used to visualize the gastrointestinal tract) to diagnose the source of bleeding and to provide treatment. Currently we use three different modalities to treat peptic ulcer bleeding: a) injection of adrenaline, b)the use of electrocautery and c)the use of mechanical devices such as clips. Most of these techniques require direct tissue contact to stop the bleeding and this can be technically challenging. Therefore, in a number of cases either the bleeding cannot be controlled at the time of the index endoscopy or there is recurrent bleeding within 72 hours of the first bleed. Recently a new technique called Hemospray (Cook Medical) has been shown to be effective in controlling bleeding from peptic ulcers. This technique utilises application of non toxic proprietary powder that is applied onto the bleeding site via endoscope using a catheter in short spray bursts. The powder adheres to the bleeding source and rapidly achieve control of bleeding. This study will evaluate the effectiveness of Hemospray to control the more serious bleeds from peptic ulcers (termed Forrest Ia and Ib).
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0334
Date of REC Opinion
12 Dec 2013
REC opinion
Further Information Favourable Opinion