Prophylactic Anticoagulation for Catheter-related Thrombosis
The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial.
1 other identifier
interventional
1,640
1 country
28
Brief Summary
The main objective of this study is to compare the efficacy and safety of aspirin, low molecule heparin and rivaroxaban for preventing catheter-related thrombosis in middle-to-high-risk ambulatory patients with cancer and implantable venous access ports.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2020
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedJune 30, 2020
January 1, 2020
1.3 years
January 12, 2020
June 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
occurrence of catheter-related thrombosis
detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary
from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle
occurrence of major-bleeding event
define occurrence of major-bleeding event with ISTH standard
from enrollment to the first time of occurrence of major-bleeding event, up to 1 month after the completion of last chemotherapy cycle
Secondary Outcomes (2)
occurrence of other thrombosis or embolism events except for catheter-related thrombosis
from enrollment to the first time of occurrence of other thrombosis or embolism events except for catheter-related thrombosis , up to 1 month after the completion of last chemotherapy cycle
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle
Study Arms (4)
Aspirin 100mg
EXPERIMENTALrivaroxaban 10mg
EXPERIMENTALlow molecule heparin
EXPERIMENTALReference
NO INTERVENTIONmechanical prophylaxis
Interventions
Eligibility Criteria
You may qualify if:
- age 18-75 years;
- patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) class 0-1;
- expected to receive chemotherapy within 1 week of enrollment;
- expected survival of more than 6 months;
- ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
- Khorana score 1-3 point.
You may not qualify if:
- patients with a history of allergies to low molecular weight heparin, rivaroxaban, aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, neurovascular edema or shock;
- patients with bleeding risks: thrombocytopenia (platelet count \< 50\*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke;
- moderate to severe liver and kidney dysfunction;
- pregnant or lactating women;
- patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
- patients taking methotrexate;
- patients with systemic use of non-steroidal anti-inflammatory drugs;
- patients who have had anticoagulant drugs for any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
the People's Hospital of Dongyang City
Dongyang, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, the Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
the First People's Hospital of Xiaoshan District, Hangzhou
Hangzhou, Zhejiang, China
Women's Hospital of School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
the Central Hospital of Huzhou City
Huzhou, Zhejiang, China
the Second Affiliated Hospital of Jiaxing College
Jiaxing, Zhejiang, China
the Women's Hospital of Jiaxing City
Jiaxing, Zhejiang, China
the Central Hospital of Jinhua City
Jinhua, Zhejiang, China
the Central Hospital of Lishui City
Lishui, Zhejiang, China
the People's Hospital of Jinyun County
Lishui, Zhejiang, China
the People's Hospital of Lishui City
Lishui, Zhejiang, China
the People's Hospital of Lishui City
Lishui, Zhejiang, China
the Women's Hospital of Lishui City
Lishui, Zhejiang, China
the Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
the Huamei Hospital of Ningbo City, University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
the People's Hospital of Yinzhou
Ningbo, Zhejiang, China
the Women's and Children's Hospital of Ningbo City
Ningbo, Zhejiang, China
the Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang, China
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
the Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
the Zhoushan Hospital of Zhejiang Province
Zhoushan, Zhejiang, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Huang, Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2020
First Posted
February 5, 2020
Study Start
May 1, 2020
Primary Completion
August 30, 2021
Study Completion
February 28, 2022
Last Updated
June 30, 2020
Record last verified: 2020-01