Bestimmung der Thromboplastinzeit mit einem neuen standardisierten Thromboplastin aus menschlicher Plazenta: Ergebnisse einer kooperativen Studie

In five centres a new sensitive standardized thromboplastin from human placenta (Thromborel S) for determination of prothrombin time (PT) was evaluated on plasmas from healthy subjects, from patients on oral anticoagulant therapy and from patients with different diseases, especially of the liver. The standardization of the human placenta thromboplastin (HPT) for prothrombin time determination was performed by comparison with a lot of the Reference Preparation British Comparative Thromboplastin (BCT). The obtained International Sensitivity Index (ISI) for 14 differents lots of the new thromboplastin varied between 1.04 and 1.29 (mean value: 1.16). The reagent is highly sensitive to the factors of the extrinsic coagulation pathway and is not affected by heparin at least up to 0.6 IU/ml. From the comparison with the British Comparative Thromboplastin lot No. 235, a therapeutical range for the stable phase of the oral anticoagulation of 2.4-4.0 prothrombin ratio or 15-27% of normal, respectively, was obtained. Comparison of prothrombin time determination using the Human Placental Thromboplastin and the British Comparative Thromboplastin lot No. 235 in 330 patients on oral anticoagulation showed good correlations either in "percent normal" or in prothrombin ratio.