Efficiency and safety evaluation of prophylaxes for venous thrombosis after gynecological surgery

Abstract

Background: In this study, we investigate the incidence of venous thrombosis (VT), and evaluate the effectiveness and safety of 3 major thromboprophylaxes and the potential risk factors for VT in women undergoing surgery for a gynecological malignancy.

Methods: We performed a randomized controlled trial of 307 patients undergoing laparoscopic surgery for gynecological malignancies at a single institution from January 2016 to October 2017. Patients were divided into 3 groups: one receiving a half dose of low-molecular-weight heparin sodium injection (FLUXUM, Alfa Wassermann, Italy) delivered by injection, one receiving a full dose of FLUXUM, and a third group receiving an Argatroban injection.

Results: None of the patients in our study developed a pulmonary embolism, bleeding, or infectious complications. There were no statistical differences in the rate of deep venous thrombosis (DVT) (0%, 0%, and 2.38%) and the superficial venous thromboembolism (SVT) (15.66%, 8.97%, and 18.6%) among the 3 groups. None of the patients developed symptomatic VT. The effect of treatment on alanine aminotransferase and aspartate aminotransferase differed between the groups, with a minimal effect in the Argatroban group, and all 3 methods resulted in minimal impairment of renal function. Decreased hemoglobin, elevated levels of D-dimer, and prothrombin time were closely related to thrombogenesis.

Conclusion: In conclusion, the incidence of postoperative thrombosis in gynecological malignancy among these Chinese people is not as low as we had originally presumed. Argatroban is not more effective than Parnaparin as a direct thrombin inhibitor, but it has less influence on liver function, which is beneficial for patients undergoing chemotherapy. Hemoglobin, D-dimer, and prothrombin time may be used to predict or detect thrombogenesis.

Figure 1

A, Number of patients with venous thrombosis following gynecological surgery in relation to tumor histopathology and site. B, Number of patients with venous thrombosis with different pathologic types of tumor and sites. They were not statistically significantly different.

Figure 2

Blood tests for renal and liver function in different treatment groups during 90-day follow-up. A, The level of ALT in each group (P < .0001 on POD7). B, The level of AST in each group (P < .0001 on POD7). C, The level of TBil in each group. D, The level of ALP in each group. E, The level of γ-GTP in each group (P = .0149 on POD7). F, Level of LDH in 3 treatment groups. No significant differences were observed. The first group (Half-FLU) was given half the usual dose of low molecular weight heparin sodium (FLUXUM) 2125KU subcutaneous injection, the second group (FLU) was given a full usual dose of FLUXUM 4250KU subcutaneous injection, and the third group (Arg) was given an Argatroban 20 mg injection. γ-GTP = γ-glutamyl transpeptidase, ALP = alkaline phosphatase, ALT = glutamic-pyruvic transaminase, Arg = argatroban IV injection, AST = glutami-oxalacetic transaminase, FLU = full usual prophylactic dose of low molecular weight heparin sodium injection, FLUXUM = low molecular weight heparin sodium injection, Half-FLU = half usual prophylactic dose of low molecular weight heparin sodium injection, LDH = lactic dehydrogenase, TBil = total bilirubin.

Figure 3

BUN and Cr, levels in different groups during the 90-day follow-up. A, BUN levels in each group. B, Cr levels in each group. BUN = blood urea nitrogen, Cr = creatinine.