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MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 1400 to confirmed 1386
Site details revised at 11 of 11 sites
v19
MinorSite contacts updated at 1 of 11 sitesv18
MinorPrimary completion date: Mar 2022 to Aug 2022
Study completion date: Mar 2027 to Aug 2027
Study sites revised (11)
v17
MinorStudy sites: 10 to 11v16
MinorStudy sites: 9 to 10
Primary completion date: Jan 2022 to Mar 2022
Study completion date: Jan 2027 to Mar 2027
Eligibility criteria expanded, about 12 words
v15
Show 13 earlier versionsHide 13 earlier versions
NotablePhase: Phase 2 to Phase 3v14Show 5 more changesShow less
Enrollment target: 400 to 1400
Primary endpoint revised
Study sites: 5 to 9
Secondary endpoints: 5 to 11
Study description expanded, about 11 words
MinorEnrollment target: 300 to 400
Secondary endpoints: details revised at 2 of 5 entries
Site contacts updated at 1 of 5 sites
Study description shortened, about 1 word
v13
NotableEnrollment target: 200 to 300
Primary completion date: Jan 2017 to Jan 2022
Study completion date: Jan 2022 to Jan 2027
v12
MinorSite contacts updated at 1 of 5 sitesv11
MinorSite details revised at 1 of 5 sitesv10
MinorSite details revised at 2 of 5 sitesv9
NotableTrial status: Active, Not Recruiting to Recruitingv8Show 7 more changesShow less
Enrollment target: 100 to 200
Primary completion date: Jul 2015 to Jan 2017
Study completion date: Dec 2015 to Jan 2022
Secondary endpoints: 4 to 5
Study description expanded, about 42 words
Site details revised at 5 of 5 sites
Eligibility criteria shortened, about 3 words
MinorTrial status: Recruiting to Active, Not Recruiting
Primary completion date changed from estimate of Oct 2015 to Jul 2015
Site details revised at 5 of 5 sites
v7
MinorSite details revised at 1 of 5 sitesv6
MinorSite details revised at 1 of 5 sitesv5
MinorSite details revised at 1 of 5 sitesv4
MinorSite details revised at 1 of 5 sitesv3
NotableTrial status: Not Yet Recruiting to Recruitingv2Show 6 more changesShow less
Primary completion date: Oct 2014 to Oct 2015
Start date: Oct 2014 to Nov 2014
Secondary endpoints: details revised at 4 of 4 entries
Site details revised at 5 of 5 sites
Collaborator revised
Study description expanded, about 3 words
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. The sample size for this study is 1230 participants.Participants enrolled in the prior Vanguard study will proceed directly into the RCT.