Clinical Trial: Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial
Brief Summary: Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.
Detailed Summary:
Sponsor: Odense University Hospital
Current Primary Outcome: Composite Endpoint [ Time Frame: Meassured after a week from primary therapeutic endoscopy ]
Patients are classified into groups depending on the worst outcome:
- No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
- No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
- Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Rebleeding requiring surgery.
- Patients who have died.
Results are compared using the Wilcoxon rank sum test.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mortality [ Time Frame: 1 month ]Patients who have died within af month from therapeutic endoscopy.
- Rebleeding [ Time Frame: 1 month ]Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
- Blood transfusion [ Time Frame: 1 month ]Amount of received blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. Patients will only receive blood transfusion if hemoglobin < 6,0mmol/L
- Surgical haemostasis [ Time Frame: 1 month ]Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
- Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ]Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Duration of hospitalization [ Time Frame: Estimated 4 days ]Time from hospitalization to discharge.
- Thromboembolic complications [ Time Frame: 1 month ]Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
Original Secondary Outcome:
- Mortality [ Time Frame: 1 month ]Patients who have died within af month from therapeutic endoscopy.
- Rebleeding [ Time Frame: 1 month ]Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
- Blood transfusion [ Time Frame: 1 month ]Amount of recieved blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. Patients will only recieve blood transfusion if hemoglobin < 6,0mmol/L
- Surgical haemostasis [ Time Frame: 1 month ]Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
- Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ]Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Duration of hospitalization [ Time Frame: Estimated 4 days ]Time from hospitalization to discharge.
- Thromboembolic complications [ Time Frame: 1 month ]Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
Information By: Odense University Hospital
Dates:
Date Received: May 10, 2010
Date Started: September 2009
Date Completion:
Last Updated: May 13, 2013
Last Verified: May 2013