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Background: Malignant tumor patients with peripherally inserted central catheter (PICC) are at high risk of developing deep venous thrombosis. Different concentrations of sealing liquid result in different outcomes. However, there is a lack of evidence of large randomized controlled trials to show the different incidences of deep vein thrombosis using different concentrations of sealing liquid. The aim of this study is to compare the difference in the incidence of deep vein thrombosis of the upper extremity in cancer patients with PICC using physiological saline, 10 U/ml heparin, and 50 U/ml heparin, separately. Methods: A three-arm, single-center, single-blind, randomized controlled trial will be performed. We plan to recruit a total of 639 cancer patients within 12 months with a follow-up period of six months. Patients will be randomized at 1:1:1 ratio by centralized service allocation concealment. Sealing liquid with different concentrations, i.e. physiological saline, 10 U/ml heparin, and 50 U/ml heparin will be administered. Primary outcome is the incidence of upper extremity venous thrombosis. Secondary outcomes include the time of thrombus and the severity of thrombosis with three grades. All randomized patients will be analyzed by intention-to-treat. Chi-square test will be used to compare the incidence of upper extremity venous thrombosis. Kaplan-Meier survival curve and log-rank test will be presented to compare thrombus in relation to time. A Cox regression will test the effect of group on thrombus, with hazard ratio adjusted for significant clinical variables. Discussion: The trial will help to resolve the uncertainty of the clinical practice of PICC catheterization liquid concentration, and to provide the basis for the implementing the clinical intervention and effectively reducing PICC-related venous thrombosis. The present study is ongoing, and data will be published in peer-reviewed journals after its conclusion. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800018391. Registered on 14 September 2018 - Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=30808. |
