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

Research output: Contribution to journalArticle

Abstract

Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-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 enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic 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 standard thromboprophylactic agent.

Original languageEnglish
Pages (from-to)1458-1465
Number of pages8
JournalJournal of Obstetrics and Gynaecology Research
Volume44
Issue number8
DOIs
Publication statusPublished - 1 Aug 2018

Fingerprint

Pentosan Sulfuric Polyester
Gynecologic Surgical Procedures
Enoxaparin
Hemorrhage
Safety
Islam
Venous Thromboembolism
Factor Xa
Low Molecular Weight Heparin
Thrombosis
Incidence
Research
Population

Keywords

  • embolism
  • enoxaparin
  • fondaparinux
  • pentosan
  • thrombosis

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

@article{7af9bfb53bd941158a556f731d33a10f,
title = "Sodium pentosan polysulfate efficacy as thromboprophylaxis agent in high-risk women following gynecological surgery",
abstract = "Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-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 enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic 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 standard thromboprophylactic agent.",
keywords = "embolism, enoxaparin, fondaparinux, pentosan, thrombosis",
author = "Ima Indirayani and {Aida Hani}, {Mohd Kalok} and {Nik Ismail}, {Nik Azuan} and Shah, {Shamsul Azhar} and Lim, {Pei Shan} and {Mohamed Ismail}, {Nor Azlin} and {Abdul Ghani}, {Nur Azurah} and Omar, {Mohd Hashim} and Shafiee, {Mohamad Nasir}",
year = "2018",
month = "8",
day = "1",
doi = "10.1111/jog.13686",
language = "English",
volume = "44",
pages = "1458--1465",
journal = "Asia-Oceania Journal of Obstetrics and Gynaecology",
issn = "1341-8076",
publisher = "Blackwell Publishing Asia",
number = "8",

}

TY - JOUR

T1 - Sodium pentosan polysulfate efficacy as thromboprophylaxis agent in high-risk women following gynecological surgery

AU - Indirayani, Ima

AU - Aida Hani, Mohd Kalok

AU - Nik Ismail, Nik Azuan

AU - Shah, Shamsul Azhar

AU - Lim, Pei Shan

AU - Mohamed Ismail, Nor Azlin

AU - Abdul Ghani, Nur Azurah

AU - Omar, Mohd Hashim

AU - Shafiee, Mohamad Nasir

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-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 enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic 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 standard thromboprophylactic agent.

AB - Aim: Sodium pentosan polysulfate (Na-PPS) is a plant-based agent that has similar action with low-molecular-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 enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic 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 standard thromboprophylactic agent.

KW - embolism

KW - enoxaparin

KW - fondaparinux

KW - pentosan

KW - thrombosis

UR - http://www.scopus.com/inward/record.url?scp=85051272090&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85051272090&partnerID=8YFLogxK

U2 - 10.1111/jog.13686

DO - 10.1111/jog.13686

M3 - Article

VL - 44

SP - 1458

EP - 1465

JO - Asia-Oceania Journal of Obstetrics and Gynaecology

JF - Asia-Oceania Journal of Obstetrics and Gynaecology

SN - 1341-8076

IS - 8

ER -