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Effects of Lipid Emulsions on Coagulation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07470385
Enrollment
6259
Registered
2026-03-13
Start date
2025-05-23
Completion date
2025-09-20
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder, Coagulation Function

Keywords

lipid emulsion, coagulation

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.

Interventions

Receiving intravenous lipid emulsions as part of routine hospital care.

Sponsors

Mimi Tang, PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026