Prevention of recurrent idiopathic gastroduodenal ulcer bleeding: a double-blind, randomised trial

Gut ◽  
2019 ◽  
Vol 69 (4) ◽  
pp. 652-657 ◽  
Author(s):  
Grace L H Wong ◽  
Louis H S Lau ◽  
Jessica Y L Ching ◽  
Yee-Kit Tse ◽  
Rachel H Y Ling ◽  
...  
Keyword(s):  
Duodenal Ulcer ◽  
Randomised Trial ◽  
Ulcer Bleeding ◽  
Recurrent Ulcer ◽  
Gi Bleeding ◽  
Double Blind ◽  
Upper Gi Bleeding ◽  
Upper Gi ◽  
History Of ◽  
Bleeding Ulcers

ObjectivePatients with a history of Helicobacter pylori-negative idiopathic bleeding ulcers have a considerable risk of recurrent ulcer complications. We hypothesised that a proton pump inhibitor (lansoprazole) is superior to a histamine 2 receptor antagonist (famotidine) for the prevention of recurrent ulcer bleeding in such patients.DesignIn this industry-independent, double-blind, randomised trial, we recruited patients with a history of idiopathic bleeding ulcers. After ulcer healing, we randomly assigned (1:1) patients to receive oral lansoprazole 30 mg or famotidine 40 mg daily for 24 months. The primary endpoint was recurrent upper GI bleeding within 24 months, analysed in the intention-to-treat population as determined by an independent adjudication committee.ResultsBetween 2010 and 2018, we enrolled 228 patients (114 patients in each study group). Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer). The cumulative incidence of recurrent upper GI bleeding in 24 months was 0.88% (95% CI 0.08% to 4.37%) in the lansoprazole arm and 2.63% (95% CI 0.71% to 6.91%) in the famotidine arm (p=0.313; crude HR 0.33, 95% CI 0.03 to 3.16, p=0.336). None of the patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs.ConclusionThis 2-year, double-blind randomised trial showed that among patients with a history of H. pylori-negative idiopathic ulcer bleeding, recurrent bleeding rates were comparable between users of lansoprazole and famotidine, although a small difference in efficacy cannot be excluded.Trial registration numberNCT01180179; Results.

Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial

The Lancet ◽  
2007 ◽  
Vol 369 (9573) ◽  
pp. 1621-1626 ◽  
Author(s):  
Francis Ka Leung Chan ◽  
Vincent Wai Sun Wong ◽  
Bing Yee Suen ◽  
Justin Che Yuen Wu ◽  
Jessica Yuet Ling Ching ◽  
...  
Keyword(s):  
High Risk ◽  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Randomised Trial ◽  
Ulcer Bleeding ◽  
Recurrent Ulcer ◽  
Double Blind ◽  
Very High

453 Natural History of Acute Upper GI Bleeding Due to Cancer: Short-Term Success and Long-Term Recurrence With or Without Endoscopic Therapy

2012 ◽  
Vol 75 (4) ◽  
pp. AB143
Author(s):  
Sarah Sheibani ◽  
Beverly Chen ◽  
John J. Kim ◽  
Saberi Behanam ◽  
Sunhee Park ◽  
...  
Keyword(s):  
Natural History ◽  
Endoscopic Therapy ◽  
Gi Bleeding ◽  
Short Term ◽  
Upper Gi Bleeding ◽  
Upper Gi ◽  
History Of

scholarly journals Tranexamic acid for acute gastrointestinal bleeding (The HALT-IT trial): Statistical analysis plan for an international, randomised, double blind, placebo-controlled trial

2019 ◽  
Author(s):  
Amy Charlotte Brenner ◽  
Adefemi Afolabi ◽  
Syed Masroor Ahmad ◽  
Monica Arribas ◽  
Rizwana Chaudhri ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Blood Transfusion ◽  
Tranexamic Acid ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gi Bleeding ◽  
Double Blind ◽  
Upper Gi Bleeding ◽  
Upper Gi ◽  
Lower Gi Bleeding

Abstract Background: Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include peptic ulcer / erosive mucosal disease, oesophageal varices and malignancy. The case fatality rate is around 10% for upper GI bleeding and 3% for lower GI bleeding. Rebleeding affects 5-40% of patients and is associated with a four-fold increased risk of death. Tranexamic acid (TXA) decreases bleeding and the need for blood transfusion in surgery and reduces death due to bleeding in patients with trauma and postpartum haemorrhage. It reduces bleeding by inhibiting the breakdown of fibrin clots by plasmin. Due to the methodological weaknesses and small size of the existing trials, the effectiveness and safety of TXA in GI bleeding is uncertain. The HALT-IT trial aims to provide reliable evidence about the effects of TXA in acute upper and lower GI bleeding. Methods: The HALT-IT trial is an international, randomised, double blind (participant and trial staff), placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8,000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive tranexamic acid (1g loading dose followed by 3g maintenance dose over 24 hours) or matching placebo. The main analysis will compare those randomised to tranexamic acid with those randomised to placebo on an intention-to-treat basis, presenting the results as effect estimates (relative risks) and confidence intervals. The primary outcome is death due to bleeding within 5 days of randomisation and secondary outcomes are rebleeding, all-cause and cause-specific mortality, thromboembolic events, complications, endoscopic, radiological and surgical interventions, blood transfusion requirements, disability (defined by a measure of patient’s self-care capacity) and number of days spent in intensive care or high dependency units. Subgroup analyses for the primary outcome will consider time to treatment, location of bleeding, cause of bleed and clinical Rockall score. Discussion: We present the statistical analysis of the HALT-IT trial. This plan was published before the treatment allocation was un-blinded.

scholarly journals Tranexamic acid for acute gastrointestinal bleeding (The HALT-IT trial): Statistical analysis plan for an international, randomised, double blind, placebo-controlled trial

2019 ◽  
Author(s):  
Amy Charlotte Brenner ◽  
Adefemi Afolabi ◽  
Syed Masroor Ahmad ◽  
Monica Arribas ◽  
Rizwana Chaudhri ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Blood Transfusion ◽  
Tranexamic Acid ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gi Bleeding ◽  
Double Blind ◽  
Upper Gi Bleeding ◽  
Upper Gi ◽  
Lower Gi Bleeding

Abstract Background: Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include peptic ulcer / erosive mucosal disease, oesophageal varices and malignancy. The case fatality rate is around 10% for upper GI bleeding and 3% for lower GI bleeding. Rebleeding affects 5-40% of patients and is associated with a four-fold increased risk of death. Tranexamic acid (TXA) decreases bleeding and the need for blood transfusion in surgery and reduces death due to bleeding in patients with trauma and postpartum haemorrhage. It reduces bleeding by inhibiting the breakdown of fibrin clots by plasmin. Due to the methodological weaknesses and small size of the existing trials, the effectiveness and safety of TXA in GI bleeding is uncertain. The HALT-IT trial aims to provide reliable evidence about the effects of TXA in acute upper and lower GI bleeding. Methods: The HALT-IT trial is an international, randomised, double blind (participant and trial staff), placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8,000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive tranexamic acid (1g loading dose followed by 3g maintenance dose over 24 hours) or matching placebo. The main analysis will compare those randomised to tranexamic acid with those randomised to placebo on an intention-to-treat basis, presenting the results as effect estimates (relative and absolute risks) and confidence intervals. The primary outcome is death due to bleeding within 5 days of randomisation and secondary outcomes are rebleeding, all-cause and cause-specific mortality, thromboembolic events, complications, endoscopic, radiological and surgical interventions, blood transfusion requirements, disability (defined by a measure of patient’s self-care capacity) and number of days spent in intensive care or high dependency units. Subgroup analyses for the primary outcome will consider time to treatment, location of bleeding, cause of bleed and clinical Rockall score. Discussion: We present the statistical analysis of the HALT-IT trial. This plan was published before the treatment allocation was un-blinded.

scholarly journals Tranexamic acid for acute gastrointestinal bleeding (The HALT-IT trial): Statistical analysis plan for an international, randomised, double blind, placebo-controlled trial

2019 ◽  
Author(s):  
Amy Charlotte Brenner ◽  
Adefemi Afolabi ◽  
Syed Masroor Ahmad ◽  
Monica Arribas ◽  
Rizwana Chaudhri ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Blood Transfusion ◽  
Tranexamic Acid ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gi Bleeding ◽  
Double Blind ◽  
Upper Gi Bleeding ◽  
Upper Gi ◽  
Lower Gi Bleeding

Abstract Background: Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include peptic ulcer / erosive mucosal disease, oesophageal varices and malignancy. The case fatality rate is around 10% for upper GI bleeding and 3% for lower GI bleeding. Rebleeding affects 5-40% of patients and is associated with a four-fold increased risk of death. Tranexamic acid (TXA) decreases bleeding and the need for blood transfusion in surgery and reduces death due to bleeding in patients with trauma and postpartum haemorrhage. It reduces bleeding by inhibiting the breakdown of fibrin clots by plasmin. Due to the methodological weaknesses and small size of the existing trials, the effectiveness and safety of TXA in GI bleeding is uncertain. The HALT-IT trial aims to provide reliable evidence about the effects of TXA in acute upper and lower GI bleeding. Methods: The HALT-IT trial is an international, randomised, double blind (participant and trial staff), placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8,000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive tranexamic acid (1g loading dose followed by 3g maintenance dose over 24 hours) or matching placebo. The main analysis will compare those randomised to tranexamic acid with those randomised to placebo on an intention-to-treat basis, presenting the results as effect estimates (relative and absolute risks) and confidence intervals. The primary outcome is death due to bleeding within 5 days of randomisation and secondary outcomes are rebleeding, all-cause and cause-specific mortality, thromboembolic events, complications, endoscopic, radiological and surgical interventions, blood transfusion requirements, disability (defined by a measure of patient’s self-care capacity) and number of days spent in intensive care or high dependency units. Subgroup analyses for the primary outcome will consider time to treatment, location of bleeding, cause of bleed and clinical Rockall score. Discussion: We present the statistical analysis of the HALT-IT trial. This plan was published before the treatment allocation was un-blinded.

Upper GI bleeding – a rare complication occurring after PEIT

2008 ◽  
Vol 29 (S 1) ◽  
Author(s):  
M Danila ◽  
I Sporea ◽  
A Tudora ◽  
R Sirli ◽  
A Popescu ◽  
...  
Keyword(s):  
Rare Complication ◽  
Gi Bleeding ◽  
Upper Gi Bleeding ◽  
Upper Gi
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