Venous Thrombosis Due to Central Venous Access Device (Disorder)Phase 4NCT04256525
Prophylactic Anticoagulation for Catheter-related Thrombosis
A Phase 4 study testing Rivaroxaban 10mg, Aspirin 100mg and low molecule heparin in people with Venous Thrombosis Due to Central Venous Access Device (Disorder) and Prophylactic Anticoagulation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 28 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Venous Thrombosis Due to Central Venous Access Device (Disorder), Prophylactic Anticoagulation, Patients With Tumor
- What is being tested?
- Rivaroxaban 10mg, Aspirin 100mg and low molecule heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- 28 sitesChina
- Study dates
- 1 May 2020to 28 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites, 28 recruiting
- Not yet recruiting
the People's Hospital of Dongyang City
Dongyang, Zhejiang
Gui Nv Hu, Doctor
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jian Huang, Doctor
- Not yet recruiting
Sir Run Run Shaw Hospital, the Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wen J Chen, Doctor
- Not yet recruiting
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Pei F Fu, Doctor
- Not yet recruiting
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhi Y Feng
- Not yet recruiting
the First People's Hospital of Xiaoshan District, Hangzhou
Hangzhou, Zhejiang
Zhen Y Wang, Doctor
- Not yet recruiting
Women's Hospital of School of Medicine Zhejiang University
Hangzhou, Zhejiang
Jing P Long, Doctor
- Not yet recruiting
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang
Xiao H Xie, Doctor
- Not yet recruiting
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang
Gui P Chen, Doctor
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Xiao C Wang, Doctor
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Shi L Tu, Doctor
- Not yet recruiting
the Central Hospital of Huzhou City
Huzhou, Zhejiang
Yun H Wei, Doctor
- Not yet recruiting
the Second Affiliated Hospital of Jiaxing College
Jiaxing, Zhejiang
Shu Z Fang, Doctor
- Not yet recruiting
the Women's Hospital of Jiaxing City
Jiaxing, Zhejiang
Juan Y Zhu, Doctor
- Not yet recruiting
the Central Hospital of Jinhua City
Jinhua, Zhejiang
Shu G Li, Doctor
- Not yet recruiting
the Central Hospital of Lishui City
Lishui, Zhejiang
Shu Z Chen, Doctor
- Not yet recruiting
the People's Hospital of Jinyun County
Lishui, Zhejiang
Qing H Shen, Doctor
- Not yet recruiting
the People's Hospital of Lishui City
Lishui, Zhejiang
Yong Shi, Doctor
- Not yet recruiting
the People's Hospital of Lishui City
Lishui, Zhejiang
Yi J Mei, Doctor
- Not yet recruiting
the Women's Hospital of Lishui City
Lishui, Zhejiang
Jia M Lei, Doctor
- Not yet recruiting
the Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Lv J Cen, Doctor
- Not yet recruiting
the Huamei Hospital of Ningbo City, University of Chinese Academy of Sciences
Ningbo, Zhejiang
Yan Zhang, Doctor
- Not yet recruiting
the People's Hospital of Yinzhou
Ningbo, Zhejiang
Ying J Wu, Doctor
- Not yet recruiting
the Women's and Children's Hospital of Ningbo City
Ningbo, Zhejiang
Zhan W Li, Doctor
- Not yet recruiting
the Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang
Jian Zhang, Doctor
- Not yet recruiting
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Ou C Wang, Doctor
- Not yet recruiting
the Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Min Zheng, Doctor
- Not yet recruiting
the Zhoushan Hospital of Zhejiang Province
Zhoushan, Zhejiang
Jing Xu, Doctor
About this study
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.
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.
Read the 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:
- 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.
Exclusion Criteria:
- 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.
- Conditions
- Venous Thrombosis Due to Central Venous Access Device (Disorder), Prophylactic Anticoagulation, Patients With Tumor
- Being tested
- Rivaroxaban 10mg, Aspirin 100mg, low molecule heparin
- Keywords
- implantable venous access ports, Catheter Related thrombosis, thromboprophylaxis, anticoagulants, aspirin, low molecule heparin, rivaroxaban, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10mgDrug
10mg orally per day
Aspirin 100mgDrug
100mg orally per day
low molecule heparinDrug
0.4ml per day subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 100mg | Experimental | Not described Receives: Drug: Aspirin 100mg |
| rivaroxaban 10mg | Experimental | Not described Receives: Drug: Rivaroxaban 10mg |
| low molecule heparin | Experimental | Not described Receives: Drug: low molecule heparin |
| Reference | No intervention | mechanical prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of catheter-related thrombosis
detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary
Measured: 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
Measured: 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
detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary
Measured: 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
define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
Measured: from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 May 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thrombosis Due to Central Venous Access Device (Disorder)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,640 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Huang, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256525
- Sponsor's protocol ID
- Research 2019-400
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04256525
- Acronym / sponsor ID
- Research 2019-400
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,640 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Exclusion Criteria:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aspirin 100mg | Experimental | Drug: Aspirin 100mg |
| rivaroxaban 10mg | Experimental | Drug: Rivaroxaban 10mg |
| low molecule heparin | Experimental | Drug: low molecule heparin |
| Reference | No intervention | –mechanical prophylaxis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 10mg10mg orally per day | Drug | rivaroxaban 10mg |
| Aspirin 100mg100mg orally per day | Drug | Aspirin 100mg |
| low molecule heparin0.4ml per day subcutaneous injection | Drug | low molecule heparin |
Primary outcome
occurrence of catheter-related thrombosis
Time frame: from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle
detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary
occurrence of major-bleeding event
Time frame: from enrollment to the first time of occurrence of major-bleeding event, up to 1 month after the completion of last chemotherapy cycle
define occurrence of major-bleeding event with ISTH standard
2 secondary outcomes
occurrence of other thrombosis or embolism events except for catheter-related thrombosis
Time frame: 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
Time frame: from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Huang, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 10mg, Aspirin 100mg and low molecule heparin in people with Venous Thrombosis Due to Central Venous Access Device (Disorder) and Prophylactic Anticoagulation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Huang, Doctor (13958123068, hjys@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of catheter-related thrombosis (time frame: from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.