Clinical trial NCT04256525: Prophylactic Anticoagulation for Catheter-related Thrombosis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Venous Thrombosis Due to Central Venous Access Device (Disorder)
Prophylactic Anticoagulation
Patients With Tumor
Keywords: implantable venous access ports
Catheter Related thrombosis
thromboprophylaxis
anticoagulants
aspirin
low molecule heparin
rivaroxaban
cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 1640
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Study Type: Interventional, randomized, parallel Assignment and no masking

Study Arms \& Intervention: Drug 1: Aspirin, 100mg/day orally; Drug 2: rivaroxaban, 10mg/day orally; Drug 3: low molecule heparin, 4000IU(0.4ml)/day subcutaneous injection; Reference: mechanical prophylaxis.

Follow-up Period: 6 months. The trial visits occurred at time before each chemotherapy cycle. The following details should be included at each visit: Khorana score, height and weight, blood routine examination, coagulation function, stool-routine and occult blood test, renal and liver function, ultrasonography of both legs and neck.

Primary Outcome: The primary efficacy end point was the occurrence of thrombus in the vein at the puncture site or nearby. The primary was the occurrence of a major bleeding event as defined by the International Society on Thrombosis and Haemostasis (ISTH).

Secondary Outcome: The secondary efficacy end point was occurrence of occurrence of other thrombosis or embolism events like deep vein thrombosis or pulmonary embolism. The secondary safety endpoint was the occurrence of any clinically relevant non-major bleeding, minor bleeding and adverse events.

Population: patients with cancer and implantable venous access ports

Eligibility Criteria:

1. Age 18-75 years;
2. Patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
4. Expected to receive chemotherapy within 1 week of enrollment;
5. Expected survival of more than 6 months;
6. Ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
7. Khorana score 1-3 point.

Exclusion Criteria:

1. 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;
2. 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;
3. moderate to severe liver and kidney dysfunction;
4. pregnant or lactating women;
5. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
6. Patients taking methotrexate;
7. Patients with systemic use of non-steroidal anti-inflammatory drugs;
8. Patients who have had anticoagulant drugs for any other reason.

Eligibility criteria: Inclusion Criteria:

1. age 18-75 years;
2. patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
4. expected to receive chemotherapy within 1 week of enrollment;
5. expected survival of more than 6 months;
6. ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
7. Khorana score 1-3 point.

Exclusion Criteria:

1. 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;
2. 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;
3. moderate to severe liver and kidney dysfunction;
4. pregnant or lactating women;
5. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
6. patients taking methotrexate;
7. patients with systemic use of non-steroidal anti-inflammatory drugs;
8. patients who have had anticoagulant drugs for any other reason.

Primary outcomes:
measure: occurrence of catheter-related thrombosis
timeFrame: from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle
measure: occurrence of major-bleeding event
timeFrame: 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:
measure: occurrence of other thrombosis or embolism events except for catheter-related thrombosis
timeFrame: 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
measure: occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
timeFrame: from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle
Other outcomes:
Locations:
city: Dongyang
country: China
facility: the People's Hospital of Dongyang City
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, the Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: the First People's Hospital of Xiaoshan District, Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: Women's Hospital of School of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of TCM
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of TCM
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Huzhou
country: China
facility: the Central Hospital of Huzhou City
state: Zhejiang
city: Jiaxing
country: China
facility: the Second Affiliated Hospital of Jiaxing College
state: Zhejiang
city: Jiaxing
country: China
facility: the Women's Hospital of Jiaxing City
state: Zhejiang
city: Jinhua
country: China
facility: the Central Hospital of Jinhua City
state: Zhejiang
city: Lishui
country: China
facility: the Central Hospital of Lishui City
state: Zhejiang
city: Lishui
country: China
facility: the People's Hospital of Jinyun County
state: Zhejiang
city: Lishui
country: China
facility: the People's Hospital of Lishui City
state: Zhejiang
city: Lishui
country: China
facility: the People's Hospital of Lishui City
state: Zhejiang
city: Lishui
country: China
facility: the Women's Hospital of Lishui City
state: Zhejiang
city: Ningbo
country: China
facility: the Affiliated Hospital of Ningbo University
state: Zhejiang
city: Ningbo
country: China
facility: the Huamei Hospital of Ningbo City, University of Chinese Academy of Sciences
state: Zhejiang
city: Ningbo
country: China
facility: the People's Hospital of Yinzhou
state: Zhejiang
city: Ningbo
country: China
facility: the Women's and Children's Hospital of Ningbo City
state: Zhejiang
city: Shaoxing
country: China
facility: the Affiliated Hospital of Shaoxing University
state: Zhejiang
city: Wenzhou
country: China
facility: the First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: the Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Zhoushan
country: China
facility: the Zhoushan Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: