Effects of Lipid Emulsions on Coagulation

Effects of Intravenous Lipid Emulsions on Coagulation Function: A Multicenter Observational Study

The goal of this observational study is to learn how intravenous lipid emulsions may affect blood clotting function in hospitalized patients. The main question it aims to answer is:

Does receiving intravenous lipid emulsions change blood clotting function in hospitalized patients?

Inpatients who received intravenous lipid emulsions as part of their regular medical care during hospitalization will be included in this study. Information about their blood clotting function before and after lipid emulsion use will be collected from existing hospital records and compared with patients who did not receive lipid emulsions. This study will not change or add to the medical care patients receive.

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder; Coagulation Function
• Intervention / Treatment: Drug: Lipid Emulsion

• Study Type: Observational
• Enrollment (Actual): 6259

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410028
      • Department of Pharmacy, Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients who received intravenous lipid emulsions as part of routine clinical care.

Description

Inclusion Criteria:

• Patients who received intravenous lipid emulsion therapy for a total duration of ≥ 5 days during hospitalization.
• Lipid emulsions include single-bottle lipid emulsion injections and commercially available three-chamber parenteral nutrition admixtures containing lipid emulsions.
• Lipid emulsions do not include anesthetic-containing formulations, such as medium- or long-chain triglyceride lipid emulsions used in propofol.

Exclusion Criteria:

• Patients who underwent major surgery with total blood loss exceeding 500 mL.
• Patients with malignant tumors who were receiving radiotherapy, chemotherapy, or immunotherapy during hospitalization.
• Patients with long-term use of anticoagulants or other medications known to affect coagulation function.
• Patients with active bleeding, any known coagulation or bleeding disorders, autoimmune diseases (e.g., primary immune thrombocytopenia), hematologic diseases (including thrombocytopenic purpura, megaloblastic anemia, aplastic anemia, or hematologic malignancies), or acquired immunodeficiency diseases.
• Patients who received blood transfusions during hospitalization.
• Patients with incomplete or missing clinical records.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lipid Emulsion Group; Patients who received intravenous lipid emulsions as part of their regular hospital care.	Drug: Lipid Emulsion; Receiving intravenous lipid emulsions as part of routine hospital care.
No Lipid Emulsion Group; Patients who did not receive intravenous lipid emulsions during their hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Count (PLT)	Platelet count measured by routine hematology testing to assess platelet levels involved in hemostasis and thrombosis.	During hospitalization (an average of 18 days)
Coagulation Time Parameters (PT, APTT, and TT)	Prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) measured by routine coagulation testing.	During hospitalization (an average of 18 days)
Fibrinogen (FIB)	Plasma fibrinogen concentration measured by routine coagulation testing to assess clotting factor levels involved in fibrin formation.	During hospitalization (an average of 18 days)
D-dimer (DD)	Plasma D-dimer level measured by routine laboratory testing to assess fibrin degradation and activation of the coagulation and fibrinolytic systems.	During hospitalization (an average of 18 days)
Fibrin/Fibrinogen Degradation Products (FDPs)	Fibrin and fibrinogen degradation products measured by routine laboratory testing to evaluate fibrinolytic activity.	During hospitalization (an average of 18 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (Hb)	Hemoglobin concentration measured by routine hematology testing.	During hospitalization (an average of 18 days)
Total Bilirubin (TBil)	Total bilirubin level measured by routine biochemical testing to assess bilirubin metabolism and liver function.	During hospitalization (an average of 18 days)
Direct Bilirubin (DBil)	Direct bilirubin level measured by routine biochemical testing as an indicator of conjugated bilirubin metabolism and hepatobiliary function.	During hospitalization (an average of 18 days)
Aspartate Aminotransferase (AST)	Aspartate aminotransferase measured by routine biochemical testing as a marker of hepatocellular injury.	During hospitalization (an average of 18 days)
Alanine Aminotransferase (ALT)	Alanine aminotransferase measured by routine biochemical testing to assess liver function.	During hospitalization (an average of 18 days)
Serum Creatinine (Scr)	Serum creatinine level measured by routine biochemical testing to evaluate renal function.	During hospitalization (an average of 18 days)
Blood Urea Nitrogen (BUN)	Blood urea nitrogen measured by routine biochemical testing to assess renal function and nitrogen metabolism.	During hospitalization (an average of 18 days)
Serum Albumin (ALB)	Serum albumin concentration measured by routine biochemical testing to evaluate nutritional and hepatic status.	During hospitalization (an average of 18 days)
Total Protein (TP)	Total protein concentration measured by routine biochemical testing to assess overall protein metabolism.	During hospitalization (an average of 18 days)

Collaborators and Investigators

• Sponsor: Mimi Tang, PhD

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: coagulation; lipid emulsion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Thrombosis; Hemostatic Disorders; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Pharmaceutical Preparations; Dosage Forms; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Emulsions; Colloids; Fat Emulsions, Intravenous
• Other Study ID Numbers: 202505055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No