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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04338386
Other study ID # YX-2020-B002
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date March 14, 2028

Study information

Verified date April 2020
Source Wuhan Asia Heart Hospital
Contact Qingkun Fan, MD
Phone 027-65796747
Email fqk@wahh.com.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Preliminary studies have shown that this novel protein F have an obvious absorption peak at about 600nm. Placed at 2-8 degrees for 7 days, protein F will be isolated from heparin plasma. To the naked eye, protein F appear to be transparent jelly between the red blood cells and the plasma. The specific protein F, how it is produced, how it causes disease are still unknown. This study will explore how to detect protein F and how it is produced.


Description:

Protein F screening was performed on anticoagulant blood plasma with heparin Lithium or blood serum by in-house turbidimetric method in Automatic biochemical analyzer.

All patients were followed-up for 3 years by telephones, routine appointment out-patient clinic or returning visit.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 14, 2028
Est. primary completion date March 14, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Testing total protein and albumin

- Testing routine blood test

Exclusion Criteria:

- high triglycerides (TG>5.00 mmol/L)

- hyperbilirubinemia (TBIL>170 mmol/L)

- fat emulsion used in past 3 days

- patients with hemolytic disease

- pregnant and lactating women

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Asia Heart Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of plasma protein F content the protein F content was measured by turbidimetric assay in automatic biochemical analyzer six month
Secondary Number of Participants with Multiple myeloma Develop or be diagnosed with multiple myeloma 3 years
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