The Clinical Outcomes of Lower Gastrointestinal Bleeding Are Not Better than Those of Upper Gastrointestinal Bleeding

Kwak, Min Seob; Myung, Jae; Han, Yong Jae; Yoon, Jin Young; Jeon, Jung Won; Shin, Hyun Phil; Joo, Kwang Ro; Lee, Joung Il

doi:10.3346/jkms.2016.31.10.1611

Cited by 23 publications

(20 citation statements)

References 31 publications

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“…Although originally developed for upper GI bleeding [17], the Rockall score has also been shown to be predictive of mortality in lower GI bleeding [34]. We do not expect the treatment effect to vary by Rockall score.…”

Section: Clinical Rockall Score (1-2 3-4 5-7)mentioning

confidence: 89%

“…We will examine the effect of tranexamic acid on death due to bleeding stratified by location (upper versus lower GI). Evidence suggests the rates of rebleeding and mortality after upper and lower GI bleeding are similar [34], and there is no reason to expect the effect of tranexamic acid to vary substantially by location of bleeding in the GI tract. Unless there is strong evidence against the null hypothesis of homogeneity of effects (i.e.…”

Section: Location Of Bleeding (Upper Gi Lower Gi)mentioning

confidence: 99%

“…This phenomenon, known as rebleeding, is common and can affect between 5% and 40% of patients with acute GI bleeding. Rebleeding is associated with a fourfold increased risk of death [10,11,16,17,34]. Some of the variation in rebleeding rates may be explained by the use of different definitions, including fresh haematemesis or melaena and recurrent hypotension or tachycardia within varying timeframes of the index bleed [18].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Brenner

Afolabi

Ahmad

et al. 2019

Preprint

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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 Haemorrhage ALleviation with Tranexamic acid -Intestinal system (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, placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive TXA (1-g loading dose followed by 3-g maintenance dose over 24 h) or matching placebo. The main analysis will compare those randomised to TXA 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.(Continued on next page)

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Section: Clinical Rockall Score (1-2 3-4 5-7)mentioning

confidence: 89%

Section: Location Of Bleeding (Upper Gi Lower Gi)mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Brenner

Afolabi

Ahmad

et al. 2019

Preprint

View full text Add to dashboard Cite

show abstract

“…GI bleeding may also be categorized based on the anatomical location of the source of bleeding. Bleeding originating from a site proximal to the ligament of Treitz, located at the duodenojejunal flexure, is called upper GI bleeding; and hemorrhage originating from a point distal to this ligament is referred to as lower GI bleeding [1][2].…”

Section: Discussionmentioning

confidence: 99%

Cavernous Hemangioma: A Rare Cause of Massive Lower Gastrointestinal Bleeding

Al-Tkrit¹,

Aneeb²,

Mekaiel³

et al. 2020

Cureus

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“…Rebleeding is associated with a four-fold increased risk of death [10,11,16,17,34]. Some of the variation in rebleeding rates may be explained by the use of different definitions, including fresh haematemesis or melaena and recurrent hypotension or tachycardia within varying timeframes of the index bleed [18].…”

Section: Introductionmentioning

confidence: 99%

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

Brenner

Afolabi

Ahmad

et al. 2019

Preprint

View full text Add to dashboard Cite

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.

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The Clinical Outcomes of Lower Gastrointestinal Bleeding Are Not Better than Those of Upper Gastrointestinal Bleeding

Cited by 23 publications

References 31 publications

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

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

Cavernous Hemangioma: A Rare Cause of Massive Lower Gastrointestinal Bleeding

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

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