Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy

NCT06293287 | Unknown Phase 2

• 1 other identifier: DJ-2023-02
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure

Conditions

Radial Artery Occlusion

Outcome Measures

Primary Outcomes (1)

• RAO rate after 24 hours and 21days

  Radial artery Doppler ultrasounds will be performed 24 hours later and again after 21 days to assess for the occurrence of RAO.

  Data will be analyzed immediately after the last participant completes the 21-day post-treatment radial artery Doppler ultrasound assessment.

Study Arms (2)

placebo

PLACEBO COMPARATOR

The control group will receive an injection of a placebo (0.9% saline solution) of equal volume once daily.

Drug: Placebo

enoxaparin sodium

ACTIVE COMPARATOR

Subjects in the experimental group will be administered subcutaneous enoxaparin sodium injections at a dose of 4000 Axa IU once daily.

Drug: Subcutaneous enoxaparin sodium

Interventions

Subcutaneous enoxaparin sodium DRUG

Subcutaneous enoxaparin sodium injections at a dose of 4000 Axa IU once daily

enoxaparin sodium

Placebo DRUG

placebo (0.9% saline solution)

placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent; Age: 18-69 years;
• Pathologically diagnosed with hepatocellular carcinoma or clinically in accordance with the American Association for the Study of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma;
• Clinical stage: BCLC stage B or C, liver function Child-Pugh class A or B$ (≤7 points)$, ECOG $score \<2$; suitable for HAIC treatment;
• Adequate hematological and organ function, i.e., based on laboratory results obtained within 7 days before treatment, such as complete blood count, liver and kidney function, coagulation function, myocardial enzymes, etc., to assess whether the patient is suitable for HAIC treatment;
• Low-risk patients for VTE (Venous Thromboembolism) according to the Padua scoring system (≤3 points).

You may not qualify if:

• Concomitant primary tumors of other organs or histologically diagnosed tumors inconsistent with hepatocellular carcinoma;
• Serious diseases of the heart, lungs, kidneys, or other organs;
• Patients who have received trans-radial interventional surgery within the past 3 months;
• Patients with thrombocytopenia $and/or $leukopenia due to cirrhosis-related coagulation disorders or splenic hyperfunction are excluded;
• Preoperative radial artery ultrasound suggests vascular anatomical abnormalities, malformations, etc., unsuitable for trans-radial interventional treatment;
• Patients with thrombotic diseases who are undergoing anticoagulation therapy;
• Any unstable conditions or situations that may jeopardize the patient's safety or their compliance with the study;
• Pregnant and lactating women.

Sponsors & Collaborators

• Zhongshan Hospital (Xiamen), Fudan University: lead

Study Sites (1)

Zhongshan Hospital, Fudan University (Xiamen Branch)

Xiamen, Fujian, 361015, China

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• BoHeng Zhang, PHD

  Zhongshan Hospital (Xiamen), Fudan University

  STUDY CHAIR

Central Study Contacts

BoHeng Zhang, PHD

CONTACT

0592-3501990; zhang.boheng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: January 31, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-01

Locations

CN (1)