Comparative Study of Heparin Lock Concentrations and Thrombosis Risk Following PICC Placement in Oncology Patients: Protocol for A Randomized Controlled Study

Abstract

Background: Cancer patients who undergo peripherally inserted central catheter (PICC) placement are predisposed to venous thromboembolism. Variations in the concentration of heparin used for catheter sealing may influence the rate of thrombosis, yet evidence from large randomized controlled trials remains limited. This study aims to compare the incidence of upper-extremity deep venous thrombosis (DVT) among cancer patients receiving three different sealing solutions physiological saline, 10 U/mL heparin, and 50 U/mL heparin after PICC insertion.

Methods: This is a single-center, single-blind, three-arm randomized controlled trial. A total of 639 adult patients with malignant tumors will be enrolled over a 12-month recruitment period and followed for six months. Participants will be randomly assigned (1:1:1) to receive one of the three sealing liquids through centralized allocation concealment. The primary outcome is the incidence of upper-extremity venous thrombosis. Secondary outcomes include the time to thrombosis onset and the severity of thrombus formation (graded in three levels). Statistical analyses will be performed on an intention-to-treat basis using chi-square tests for incidence comparison, Kaplan–Meier survival analysis with log-rank tests for time-to-event data, and Cox regression modeling to estimate adjusted hazard ratios for significant clinical variables.

Discussion: The trial is designed to clarify whether different concentrations of heparin sealing solutions affect the risk of PICC-related thrombosis in patients with cancer. The findings will help inform clinical guidelines regarding optimal catheter maintenance protocols and may contribute to reducing the incidence of catheter-associated thrombotic events in oncology care.