The role of hemostatic monitoring of dabigatran etexilate in patients with proximal femur fracture undergoing bipolar endoprosthesis

Abstract

Thromboembolic diseases are major cause of morbidity and mortality in the developed world as a result of an excessive stimulation of coagulation. Major surgery, especially in trauma patients with femur fracture, is recognized as risk factor for thromboembolic event because of which thromboprophylactic medicaments are necessary. Thrombin is a key serine protease in coagulation cascade and numerous efforts have been made to develop safe and effective orally active direct thrombin inhibitor (DTI). Dabigatran etexilate is a synthetic, reversible DTI with high affinity and specificity for its target, binding both free and clot -bound thrombin and offers a favorable pharmacokinetic profile. The study was conducted to evaluate the role of haemostatic monitoring in patients with bipolar prosthesis after proximal femur fracture using dabigatran for thromboprophylaxis. The study was performed according the third degree criteria for clinical investigation for drug application. Patients were divided in two groups according to the age related dabigatran dosage (150mg/twice daily in 65-70 years group and 110mg/twice daily in 70-75 years group). Informed consent was provided from all the patients. There were 42 investigated patients with implanted femur prosthesis. Haemostatic monitoring (platelet count, PT, APTT, TT, DD, PC, PS, ATIII) of patients receiving dabigatran was performed in order to evaluate the anticoagulant effect of the drug. Haemostatic monitoring was performed preoperative and also at 1, 7, 14, 21, 28 and 35 postoperative day. Color doppler ultrasonography investigation was performed at 7 and 35 days after the operation. In all of the patients, significant changes were observed only in APTT, TT and DD values which was not related to the dabigatran dose regiment. There were no thrombotic or hemorrhagic complications observed in none of the investigated patients which is due to the appropriate prophylactic doses of dabigatran.