Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Effects of Antithrombin Versus Placebo on the...

Area of Science:

• Cardiovascular Surgery
• Pediatric Anesthesiology
• Hematology

Background:

• Infants undergoing cardiopulmonary bypass (CPB) often have low antithrombin levels.
• Low antithrombin levels can impair heparin efficacy and increase bleeding risk during CPB.

Purpose of the Study:

• To evaluate if normalizing antithrombin levels to 100% in infants undergoing CPB improves heparin sensitivity and anticoagulation.
• To assess the postoperative benefits of antithrombin supplementation, including bleeding and blood product usage.

Main Methods:

• A randomized, double-blinded, placebo-controlled prospective study involving 40 infants (<7 months) with preoperative antithrombin levels <70%.
• Infants received either exogenous antithrombin to reach 100% functional level or placebo intraoperatively before CPB.
• Data collected included activated clotting times, heparin sensitivity, chest tube output, blood product exposure, antithrombin levels, and D-dimer levels up to postoperative day 4.

Main Results:

• The antithrombin group showed increased heparin sensitivity and higher post-heparin activated clotting times.
• Significantly lower 24-hour chest tube output and overall blood product exposure were observed in the antithrombin group.
• Functional antithrombin levels remained higher in the treatment group until postoperative day 2, with significantly lower D-dimer levels on postoperative day 4.

Conclusions:

• Antithrombin supplementation in infants with low levels effectively improves heparin sensitivity and anticoagulation during CPB.
• This intervention does not increase bleeding or adverse events and demonstrates significant postoperative benefits, including reduced bleeding and blood product requirements.
• Supplementation may also mitigate the prothrombotic state post-CPB, as indicated by lower D-dimer levels.