Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone in the Treatment of Hypertriglyceridemic Pancreatitis (LIHTGP Trial): Study Protocol for a Multicenter, Prospective, Single-Blind, Randomized Controlled Trial.

Abstract

Currently, insulin and/or heparin/low-molecular-weight heparin (LMWH) serve as an early lipid-lowering treatment for hypertriglyceridemic pancreatitis (HTGP). However, whether the clinical prognosis of combining LMWH with insulin is superior to using insulin alone remains unknown. This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients. In total, 476 eligible participants will be recruited from 18 hospitals throughout China. Participants in the LMWH group will receive LMWH combined with insulin, whereas insulin alone will be administered to those in the insulin group. The patients will be followed up at 3 and 6 months after discharge. Adverse reactions will be evaluated by the safety monitoring committee. Safety outcomes and adverse events will also be recorded. The study is registered in the Chinese Clinical Trial Registry (No: ChiCTR1900023640). Recruitment will begin in August 2019 and will be completed in December 2021 (http://www.chictr.org.cn/index.aspx). No data are available now. The trial will investigate the efficacy of using LMWH combined with insulin as an emergency lipid-lowering treatment in reducing new organ failure, mortality, hospital stays, and expenses compared using with insulin alone for patients with HTGP.