At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 200 enrolled
Drug / intervention
Antithrombin IIIdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
In Brief
A Phase 2 clinical trial evaluating Antithrombin III for Acquired Antithrombin III Deficiency and Coronary Artery Bypass. Completed, enrolled 200 participants across 1 site.
Detailed Summary
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartJun 2009
Primary CompletionJun 2011
Study CompletionSep 2011
TodayJul 2026
First PostedJan 15, 2009
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.5 years ago
Interventions
Antithrombin IIIdrug
Single dose of antithrombin III sufficient to achieve a preoperative level of 120%