Effects of Lipid Emulsions on Coagulation

NCT07470385 | Completed

• 1 other identifier: 202505055
• Study Type: observational
• Target: 6,259
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coagulation Disorder; Coagulation Function

Keywords

lipid emulsion; coagulation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Hemoglobin (Hb)

  During hospitalization (an average of 18 days)

• Total Bilirubin (TBil)

  During hospitalization (an average of 18 days)

• Direct Bilirubin (DBil)

  During hospitalization (an average of 18 days)

• Aspartate Aminotransferase (AST)

  During hospitalization (an average of 18 days)

• Alanine Aminotransferase (ALT)

  During hospitalization (an average of 18 days)

Study Arms (2)

Lipid Emulsion Group

Patients who received intravenous lipid emulsions as part of their regular hospital care.

Drug: Lipid Emulsion

No Lipid Emulsion Group

Patients who did not receive intravenous lipid emulsions during their hospital stay.

Interventions

Lipid Emulsion DRUG

Receiving intravenous lipid emulsions as part of routine hospital care.

Lipid Emulsion Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mimi Tang, PhD: lead

Study Sites (1)

Department of Pharmacy, Xiangya Hospital, Central South University

Changsha, Hunan, 410028, China

Location

MeSH Terms

Conditions

Hemostatic Disorders; Thrombosis

Interventions

Fat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 13, 2026
• Study Start: May 23, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)