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RCT · 2018 · n=109

Sodium pentosan polysulfate efficacy as thromboprophylaxis agent in high-risk women following gynecological surgery

Indirayani I, Kalok A, Nik Ismail NA, Shah SA, Lim PS, Mohamed Ismail NA, Nur Azurah AG, Omar MH, Shafiee MN · The Journal of Obstetrics and Gynaecology Research

Strongcounts toward this tier

The clearest human read on what subcutaneous PPS does to bleeding: minor bleeding occurred in 28.3% of the PPS group versus 5.4% on standard prophylaxis (p=0.001). No major bleeding and no venous thromboembolism occurred in either arm, so the trial could not judge efficacy.

Population
109 women at high thromboembolic risk after major gynaecological surgery
Intervention
Subcutaneous sodium PPS 50 mg twice daily from 6 hours postoperatively, at least 3 days
Comparator
Subcutaneous enoxaparin 40 mg daily, or fondaparinux 2.5 mg daily
Limitations
Open-label, 109 women, three days of dosing in the immediate postoperative period — the highest-risk bleeding window there is, and twice-daily dosing far denser than an arthritis course; zero events in the efficacy endpoint leave the comparison underpowered.

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