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Gastrointestinal Hemorrhage clinical trials

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NCT ID: NCT02375646 Not yet recruiting - Clinical trials for Gastrointestinal Hemorrhage

Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients

Start date: May 2015
Phase: N/A
Study type: Interventional

One of the well-known of complications post colonic polypectomy is bleeding usually occuring in the 2-week period following the procedure. Patients treated with oral anticoagulation (e.g. Warfarin) are a special and challenging patient group due to the need on the one hand to prevent thromboembolic events, and on the second hand to minimize the risk of post-polypectomy bleeding. Current practice guidelines recommend holding Warfarin treatment while bridging with LMW Heparin while resuming Warfarin treatment following the procedure. This practice was found to be associated with a much higher rate of bleeding compared with continuing Warfarin in a recent prospective trial in pacemaker transplanted patients. The fact that most post-polypectomy bleeding occurs within the 2-week period further questions the current practice of periprocedural bridging therapy. the investigators therefore hypothesize that patients with continuous Warfarin treatment may have similar post-polypectomy bleeding rates compared to patients receiving bridging therapy with LMW Heparin. This is a multicenter single-blinded prospective randomized trial comparing small post-polypectomy (polyps<10mm) bleeding rates between two groups of patients: Continuous therapy with Warfarin, vs. LMW Heparin therapy while withholding Warfarin therapy (current practice).

NCT ID: NCT02349490 Completed - Clinical trials for Gastrointestinal Hemorrhage

Seraseal for Endoscopic Hemostasis

Start date: November 2011
Phase: Phase 4
Study type: Interventional

Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal is applied after an initial failure of the institutional standard method. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.

NCT ID: NCT02315404 Terminated - Clinical trials for Obscure Gastrointestinal Bleeding

Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial

Start date: January 2014
Phase: N/A
Study type: Interventional

Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel. The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.

NCT ID: NCT02301949 Withdrawn - Clinical trials for Gastrointestinal Vascular Malformation

Retreatment and Its Efficiency of Thalidomide for Vascular Malformation Patients With Failure of First Course Treatment

Start date: December 2015
Phase: Phase 2
Study type: Interventional

Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge. Methods: The investigators will perform a randomized, double blind, placebo controlled study of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients with failure of first course treatment of thalidomide will be randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide or placebo orally four times daily. All patients will be monitored for at least one year. The primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50% at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes include the participants dependent on blood transfusions and changes from baseline in transfused packed red cell units, bleeding episodes, and hemoglobin levels at 12 months. Statistical significance is defined at P < 0.05.

NCT ID: NCT02235311 Terminated - Clinical trials for Upper Gastrointestinal Bleed

Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed

Start date: October 2014
Phase: N/A
Study type: Interventional

Despite recommendations from clinical practice guidelines to discharge patients from the hospital on once daily proton pump inhibitors after acute management of UGIB, clinical practice is to use twice daily proton pump inhibitor therapy. The objective of this study will be to assess whether or not once daily pantoprazole is non-inferior to twice daily pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe for any potential difference in safety for once daily versus twice daily proton pump inhibitors.

NCT ID: NCT02219568 Completed - Clinical trials for Gastrointestinal Bleeding

Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the efficacy between video capsule endoscopy and CT enterography in diagnosis of obscure gastrointestinal bleeding.

NCT ID: NCT02150941 Terminated - Clinical trials for Gastrointestinal Hemorrhage

Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding

Start date: April 2015
Phase: N/A
Study type: Interventional

Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel. A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.

NCT ID: NCT02135627 Completed - Clinical trials for MALIGNANT GASTROINTESTINAL BLEEDING

TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

Start date: April 2014
Phase: N/A
Study type: Interventional

Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery. All exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13). The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14). More robust controlled evaluative data are now needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (RCT).

NCT ID: NCT02105532 Completed - Clinical trials for Gastrointestinal Hemorrhage

Transfusion in Gastrointestinal Bleeding

TRIGGER
Start date: September 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.

NCT ID: NCT02099435 Completed - Colonic Polyp Clinical Trials

Study of Hemospray for Lower Gastrointestinal Hemorrhage

Start date: January 2015
Phase: N/A
Study type: Observational

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.