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Completed

NCT Number: NCT07470385

Effects of Lipid Emulsions on Coagulation

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.

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Key information

Conditions

Coagulation Disorder Cardiovascular Diseases Coagulation Function Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pharmacy, Xiangya Hospital, Central South University

Changsha, Hunan, 410028, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipid Emulsion

Drug

Receiving intravenous lipid emulsions as part of routine hospital care.

Primary outcomes

  1. Platelet Count (PLT)

    Time frame: During hospitalization (an average of 18 days)

    Platelet count measured by routine hematology testing to assess platelet levels involved in hemostasis and thrombosis.

  2. Coagulation Time Parameters (PT, APTT, and TT)

    Time frame: During hospitalization (an average of 18 days)

    Prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) measured by routine coagulation testing.

  3. Fibrinogen (FIB)

    Time frame: During hospitalization (an average of 18 days)

    Plasma fibrinogen concentration measured by routine coagulation testing to assess clotting factor levels involved in fibrin formation.

  4. D-dimer (DD)

    Time frame: During hospitalization (an average of 18 days)

    Plasma D-dimer level measured by routine laboratory testing to assess fibrin degradation and activation of the coagulation and fibrinolytic systems.

  5. Fibrin/Fibrinogen Degradation Products (FDPs)

    Time frame: During hospitalization (an average of 18 days)

    Fibrin and fibrinogen degradation products measured by routine laboratory testing to evaluate fibrinolytic activity.

Secondary outcomes

  1. Hemoglobin (Hb)

    Time frame: During hospitalization (an average of 18 days)

    Hemoglobin concentration measured by routine hematology testing.

  2. Total Bilirubin (TBil)

    Time frame: During hospitalization (an average of 18 days)

    Total bilirubin level measured by routine biochemical testing to assess bilirubin metabolism and liver function.

  3. Direct Bilirubin (DBil)

    Time frame: During hospitalization (an average of 18 days)

    Direct bilirubin level measured by routine biochemical testing as an indicator of conjugated bilirubin metabolism and hepatobiliary function.

  4. Aspartate Aminotransferase (AST)

    Time frame: During hospitalization (an average of 18 days)

    Aspartate aminotransferase measured by routine biochemical testing as a marker of hepatocellular injury.

  5. Alanine Aminotransferase (ALT)

    Time frame: During hospitalization (an average of 18 days)

    Alanine aminotransferase measured by routine biochemical testing to assess liver function.

  6. Serum Creatinine (Scr)

    Time frame: During hospitalization (an average of 18 days)

    Serum creatinine level measured by routine biochemical testing to evaluate renal function.

  7. Blood Urea Nitrogen (BUN)

    Time frame: During hospitalization (an average of 18 days)

    Blood urea nitrogen measured by routine biochemical testing to assess renal function and nitrogen metabolism.

  8. Serum Albumin (ALB)

    Time frame: During hospitalization (an average of 18 days)

    Serum albumin concentration measured by routine biochemical testing to evaluate nutritional and hepatic status.

  9. Total Protein (TP)

    Time frame: During hospitalization (an average of 18 days)

    Total protein concentration measured by routine biochemical testing to assess overall protein metabolism.

Sponsors and collaborators

Lead sponsor

Mimi Tang, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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