Protocol for the impact of medication therapy management on efficacy and safety of postoperative anticoagulation therapy in patients with colorectal cancer: an open-label, prospective and randomized clinical trial.

IF 2.7 4区医学 Q3 ONCOLOGY

Chinese clinical oncology Pub Date : 2026-02-01 DOI:10.21037/cco-25-111

Jieling Mao, Zhikun Liang, Min Gao, Xiaoyan Huang, Jingwen Xie, Chunmei Dai, Jianfu Zhao, Yongjuan Ding, Genshen Ye, Yaobo Wang, Li Qin, Xiaoyan Li

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引用次数: 0

Abstract

Background: Anticoagulants, classified as high-risk medications, are commonly used and are associated with significant potential harm in postoperative patients. Patients with colorectal cancer (CRC) are among the most susceptible populations. Single-component pharmacist intervention has demonstrated conflicting efficacy in improving anticoagulant safety. Meanwhile, it remains unclear whether comprehensive medication therapy management (MTM), which integrates medication review, personalized education, and long-term follow-up, can effectively reduce adverse drug events (ADEs). This study aims to assess the impact of a comprehensive MTM pathway on anticoagulant-related ADEs in this high-risk population.

Methods: This study will be a prospective, multicenter, open-label, randomized, parallel-group trial designed to assess the impact of the MTM pathway on anticoagulant efficacy and safety in patients diagnosed with CRC, admitted for elective radical surgery, and developing acute venous thromboembolism (VTE) that requires long-term anticoagulant therapy in comparison with the current clinical standard of care. In total, 327 patients will be enrolled with randomization at a 1:1 ratio into intervention and control groups. Patients in the intervention group will receive MTM interventions at three key time points: during hospitalization, at discharge, and post-discharge. A total of 9 times of MTM services will be provided to patients within 6 months after discharge. The primary outcome is anticoagulant-related clinically important medication errors (CIME), including preventable or ameliorable ADEs and potential ADEs. The secondary outcomes are (I) preventable or ameliorable ADEs; (II) potential ADEs due to discrepancies or non-adherence; and (III) preventable or ameliorable ADEs judged to be serious, life-threatening, or fatal. Intention-to-treat (ITT) analysis will serve as the primary analytical approach.

Discussion: This study will provide evidence on whether the MTM pathway improves the efficacy and safety of anticoagulant therapy in patients with CRC who develop postoperative VTE.

Trial registration: NCT06998745 (date of registration: 2025-5-10) (Protocol version: 2024-7-16, Version 2.0).

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药物治疗管理对结直肠癌患者术后抗凝治疗疗效和安全性的影响方案：一项开放标签、前瞻性、随机临床试验。

背景：抗凝药物被列为高危药物，在术后患者中被广泛使用，并且存在显著的潜在危害。结直肠癌（CRC）患者是最易感人群之一。单组分药师干预在提高抗凝血药物安全性方面的疗效存在矛盾。同时，综合药物治疗管理（comprehensive medication therapy management， MTM），即结合用药回顾、个性化教育和长期随访的方法，能否有效减少药物不良事件（adverse drug events, ADEs），目前尚不清楚。本研究旨在评估综合MTM途径对高危人群抗凝相关ade的影响。方法：本研究将是一项前瞻性、多中心、开放标签、随机、平行组试验，旨在评估MTM途径对诊断为结直肠癌、接受选择性根治性手术、发展为需要长期抗凝治疗的急性静脉血栓栓塞（VTE）患者的抗凝疗效和安全性的影响，并与目前的临床护理标准进行比较。共有327例患者将按1:1的比例随机分为干预组和对照组。干预组患者在住院期间、出院时和出院后三个关键时间点接受MTM干预。出院后6个月内共为患者提供9次MTM服务。主要结局是抗凝相关临床重要用药错误（CIME），包括可预防或可改善的不良事件和潜在的不良事件。次要结局是(1)可预防或可改善的不良事件；（II）由于差异或不遵守规定而可能发生的不良反应；（III）可预防或可改善的严重、危及生命或致命的不良反应。意向治疗（ITT）分析将作为主要的分析方法。讨论：本研究将为MTM途径是否提高结直肠癌术后静脉血栓栓塞患者抗凝治疗的有效性和安全性提供证据。试验注册：NCT06998745（注册日期：2025-5-10）（协议版本：2024-7-16,2.0版本）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Chinese clinical oncology ONCOLOGY-

CiteScore

3.90

自引率

0.00%

发文量

期刊介绍： The Chinese Clinical Oncology (Print ISSN 2304-3865; Online ISSN 2304-3873; Chin Clin Oncol; CCO) publishes articles that describe new findings in the field of oncology, and provides current and practical information on diagnosis, prevention and clinical investigations of cancer. Specific areas of interest include, but are not limited to: multimodality therapy, biomarkers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to cancer. The aim of the Journal is to provide a forum for the dissemination of original research articles as well as review articles in all areas related to cancer. It is an international, peer-reviewed journal with a focus on cutting-edge findings in this rapidly changing field. To that end, Chin Clin Oncol is dedicated to translating the latest research developments into best multimodality practice. The journal features a distinguished editorial board, which brings together a team of highly experienced specialists in cancer treatment and research. The diverse experience of the board members allows our editorial panel to lend their expertise to a broad spectrum of cancer subjects.