Coagulation DisorderNCT07470385
Effects of Lipid Emulsions on Coagulation
An observational study of Coagulation Disorder and Coagulation Function, run by Mimi Tang, PhD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coagulation Disorder, Coagulation Function
- What is being tested?
- Lipid Emulsion
- Type of treatment
- Injection or infusion
- How many people
- 6,259 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2025to 20 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients who received intravenous lipid emulsions as part of routine clinical care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pharmacy, Xiangya Hospital, Central South University
Changsha, Hunan, 410028
About this study
Official title: 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.
- Conditions
- Coagulation Disorder, Coagulation Function
- Being tested
- Lipid Emulsion
- Keywords
- lipid emulsion, coagulation
- Medical subject headings
- Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid EmulsionDrug
Receiving intravenous lipid emulsions as part of routine hospital care.
| Study group | Role | What they receive |
|---|---|---|
| Lipid Emulsion Group | Patients who received intravenous lipid emulsions as part of their regular hospital care. Receives: Drug: Lipid Emulsion | |
| No Lipid Emulsion Group | Patients who did not receive intravenous lipid emulsions during their hospital stay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Count (PLT)
Platelet count measured by routine hematology testing to assess platelet levels involved in hemostasis and thrombosis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During hospitalization (an average of 18 days)
Secondary outcomes (9)
Hemoglobin (Hb)
Hemoglobin concentration measured by routine hematology testing.
Measured: 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.
Measured: 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.
Measured: During hospitalization (an average of 18 days)
Aspartate Aminotransferase (AST)
Aspartate aminotransferase measured by routine biochemical testing as a marker of hepatocellular injury.
Measured: During hospitalization (an average of 18 days)
Alanine Aminotransferase (ALT)
Alanine aminotransferase measured by routine biochemical testing to assess liver function.
Measured: During hospitalization (an average of 18 days)
Serum Creatinine (Scr)
Serum creatinine level measured by routine biochemical testing to evaluate renal function.
Measured: 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.
Measured: During hospitalization (an average of 18 days)
Serum Albumin (ALB)
Serum albumin concentration measured by routine biochemical testing to evaluate nutritional and hepatic status.
Measured: During hospitalization (an average of 18 days)
Total Protein (TP)
Total protein concentration measured by routine biochemical testing to assess overall protein metabolism.
Measured: During hospitalization (an average of 18 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 May 2025
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimi Tang, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mimi Tang, PhD, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470385
- Sponsor's protocol ID
- 202505055
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lipid Emulsions on Coagulation Function: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07470385
- Acronym / sponsor ID
- 202505055
- Conditions
- Coagulation Disorder, Coagulation Function
- Keywords
- lipid emulsion, coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,259 participants (actual)
- Lead sponsor
- Mimi Tang, PhDUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipid Emulsion Group | – | Drug: Lipid EmulsionPatients who received intravenous lipid emulsions as part of their regular hospital care. |
| No Lipid Emulsion Group | – | –Patients who did not receive intravenous lipid emulsions during their hospital stay. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients who received intravenous lipid emulsions as part of routine clinical care.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid EmulsionReceiving intravenous lipid emulsions as part of routine hospital care. | Drug | Lipid Emulsion Group |
Primary outcome
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.
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.
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.
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.
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.
9 secondary outcomes
Hemoglobin (Hb)
Time frame: During hospitalization (an average of 18 days)
Total Bilirubin (TBil)
Time frame: During hospitalization (an average of 18 days)
Direct Bilirubin (DBil)
Time frame: During hospitalization (an average of 18 days)
Aspartate Aminotransferase (AST)
Time frame: During hospitalization (an average of 18 days)
Alanine Aminotransferase (ALT)
Time frame: During hospitalization (an average of 18 days)
Serum Creatinine (Scr)
Time frame: During hospitalization (an average of 18 days)
Blood Urea Nitrogen (BUN)
Time frame: During hospitalization (an average of 18 days)
Serum Albumin (ALB)
Time frame: During hospitalization (an average of 18 days)
Total Protein (TP)
Time frame: During hospitalization (an average of 18 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Coagulation Disorder
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Disorder and Coagulation Function, run by Mimi Tang, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Count (PLT) (time frame: During hospitalization (an average of 18 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.