Sodium pentosan polysulfate efficacy as thromboprophylaxis agent in high-risk women following gynecological surgery Ima Indirayani 1,2 , Aida Kalok 1 , Nik A. Nik Ismail 3 , Shamsul A. Shah 4,5 , Pei S. Lim 1 , Nor A. Mohamed Ismail 1 , Abdul G. Nur Azurah 1 , Mohd Hashim Omar 1 and Mohamad N. Shafiee 1 Departments of 1 Obstetrics and Gynecology, 3 Radiology, 4 Community Health, Faculty of Medicine, UKM Medical Centre, 5 UKM Medical Molecular Biology Institute (UMBI), Kuala Lumpur, Malaysia; and 2 Department of Obstetrics and Gynecology, Faculty of Medicine, Syiah Kuala University, Banda Aceh, Indonesia Abstract Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecu- lar-weight heparin. It inhibits factor Xa, preventing blood clot formation. To date, its use in clinical practice as thromboprophylaxis agent is still limited. In addition, the efficacy and safety profile of this agent was not robustly reported globally, especially for countries with major Muslim population. We hypothesized that Na-PPS was equally effective as the standard thromboprophylaxis. We aim to compare the efficacy and safety of Na-PPS against standard agent (fondaparinux or enoxaparin). Methods: This was a randomized control, open-label trial. Women underwent major gynecological surgery were randomized to receive either subcutaneous 50 mg of Na-PPS twice daily or subcutaneous enoxaparin 40 mg once daily. Fondaparinux 2.5 mg once daily was given to Muslim women as an alternative to enoxa- parin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thrombo- embolic deterrent stockings. The primary efficacy outcome was venous thromboembolism up to 3 days postsurgery. The main safety outcomes were minor and major bleeding. Results: Among 109 participants, there was no incidence of venous thromboembolism. None of the women developed major bleeding. Minor bleeding was observed in 28.3% (15/53) and 5.4% (3/56) of Na-PPS and standard thromboprophylaxis group, respectively (P = 0.001). Conclusion: Na-PPS was associated with increased risk of minor bleeding. There was insufficient data to conclude its efficacy as thromboprophylaxis. Further research is needed to evaluate Na-PPS safety as a stan- dard thromboprophylactic agent. Key words: embolism, enoxaparin, fondaparinux, pentosan, thrombosis. Introduction Venous thromboembolism (VTE) is a well-recognized surgical complication with increased risk or morbidity and mortality. The prevalence of deep vein thrombo- sis (DVT) in surgical patients ranges between 15% and 30%, while fatal pulmonary embolism (PE) rate is 0.2–0.9%. 1 Previous VTE, advanced age, malignancy, prolonged surgical time and prior pelvic radiation therapy are among the independent risk factors for VTE in women undergoing major gynecological procedures. 1,2 It has been well documented that the incidence of VTE can be significantly reduced by both mechanical Received: November 16 2017. Accepted: April 21 2018. Correspondence: Dr Aida Kalok, Department of Obstetrics and Gynecology, Faculty of Medicine, UKM Medical Centre, Cheras 56000, Kuala Lumpur, Malaysia. Email: aida.kalok@gmail.com 1 © 2018 Japan Society of Obstetrics and Gynecology doi:10.1111/jog.13686 J. Obstet. Gynaecol. Res. 2018