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Spots Global Cancer Trial Database for Prophylactic Anticoagulation for Catheter-related Thrombosis

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Trial Identification

Brief Title: 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 ID: NCT04256525

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jian Huang, Doctor

Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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