Prophylactic Anticoagulation for Catheter-related Thrombosis

Patients With Tumor Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256525
• Other study ID #: Research 2019-400
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jian Huang, Doctor
• Phone: 13958123068
• Email: hjys[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1640
• Est. completion date: February 28, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patients With Tumor
• Prophylactic Anticoagulation
• Thrombosis
• Venous Thrombosis
• Venous Thrombosis Due to Central Venous Access Device (Disorder)

Intervention

Drug:
• Rivaroxaban 10mg
10mg orally per day
• Aspirin 100mg
100mg orally per day
• low molecule heparin
0.4ml per day subcutaneous injection

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	occurrence of other thrombosis or embolism events except for catheter-related thrombosis	detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary	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
Secondary	occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event	define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0	from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle