A Pilot Study of Antithrombin Replacement Prior to Cardiopulmonary Bypass in Neonates.
Artif Organs
; 40(1): 80-5, 2016 Jan.
Article
in En
| MEDLINE
| ID: mdl-26620919
ABSTRACT
Neonates have low levels of antithrombin. Inadequate anticoagulation during cardiopulmonary bypass (CPB) due to low antithrombin activity may result in a poor preservation of the coagulation system during bypass. We hypothesize that antithrombin replacement to neonates prior to CPB will preserve the hemostatic system and result in less postoperative bleeding. A randomized, double-blinded, placebo-controlled pilot study of antithrombin replacement to neonates prior to CPB was conducted. Preoperative antithrombin levels determined the dose of recombinant antithrombin or placebo to be given. Antithrombin levels were measured following the dosing of the antithrombin/placebo, after initiation of bypass, near the completion of bypass, and upon intensive care unit admission. Eight subjects were enrolled. No subject had safety concerns. Mediastinal exploration occurred in two antithrombin subjects and one placebo subject. Antithrombin activity levels were significantly higher in the treated group following drug administration; levels continued to be higher than preoperatively but not different from the placebo group at all other time points. Total heparin administration was less in the antithrombin group; measurements of blood loss were similar in both groups. A single dose of recombinant antithrombin did not maintain 100% activity levels throughout the entire operation. Although no safety concerns were identified in this pilot study, a larger trial is necessary to determine clinical efficacy.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Blood Coagulation
/
Cardiopulmonary Bypass
/
Antithrombin III
/
Postoperative Hemorrhage
/
Heart Defects, Congenital
/
Anticoagulants
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
Limits:
Humans
/
Newborn
Country/Region as subject:
America do norte
Language:
En
Journal:
Artif Organs
Year:
2016
Document type:
Article
Affiliation country:
United States