NCT02037555

Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass

A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiac Surgery With Cardiopulmonary Bypass

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III \[Human\]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who meet the study eligibility criteria were planned to be randomized to receive either AT-III (Human) or placebo.

Detailed description

The primary objective of this clinical study was to compare the percentage of subjects with any component of a 7 item major morbidity composite (postoperative mortality, stroke, acute kidney injury (\[AKI\]), surgical re-exploration, arterial or venous thromboembolic event, prolonged mechanical ventilation, or infection) between 2 groups of subjects randomly allocated to receive preoperative supplementation of AT-III (Human) (Antithrombin-III (\[Human \]) or Placebo. The secondary objectives of this clinical study were the following: * To compare postoperative antithrombin III (AT) levels at the Intensive Care Unit (ICU) admission between the AT-III (Human) treatment group and Placebo control group * To compare the following perioperative outcomes between the AT-III (Human) treatment group and Placebo control group: * Postoperative chest-drain blood loss in the first 12 and 24 hours after surgery * Transfusion requirements * Need for surgical re-exploration * Low cardiac output syndrome * Myocardial Infarction (MI) * Stroke * AKI * Arterial or venous thromboembolic events * Infections * Prolonged mechanical ventilation (\>24 hours) * All-cause postoperative mortality * ICU stay duration * Prolonged ICU stay (\>6 days) * Length of hospital stay Additionally, safety objectives included the evaluation of AT III (Human) for clinical safety including adverse events (AEs), risks for bleeding, clinical laboratory testing, physical exam, and vital signs.

Conditions

• Cardiac Surgery
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
BIOLOGICAL	AT-III (Human)	AT-III (Human) is an antithrombin concentrate prepared from pooled human plasma. AT-III (Human) is provided as a freeze-dried preparation for intravenous use. The AT-III (Human) preparation is reconstituted in 10 or 20 mL of sterile water for injection prior to intravenous administration.
OTHER	Placebo	0.9% Sodium Chloride for Injection, United States Pharmacopeia

Timeline

• Start date: 2014-06-26
• Primary completion: 2018-01-25
• Completion: 2018-01-25
• First posted: 2014-01-16
• Last updated: 2019-03-15
• Results posted: 2019-02-15

Locations

41 sites across 1 country: United States