- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05059431
The Effect of Human Prostate Tissue on Platelet Activation
September 19, 2021 updated by: Wei-Hung Chan, Tri-Service General Hospital
The Effect of Human Prostate Tissue on Platelet CD40 Ligand, Toll-like Receptor 4, P-selectin and Platelet-Leukocyte Aggregation: an In Vitro Study
Transurethral resection of the prostate (TURP) is a common and standard urological surgical procedure for managing benign prostatic hyperplasia (BPH).
Although surgical technology improved in recent decades, severe complications such as TURP syndrome, hematuria, and postoperative hemorrhage were still considerable.
Coagulopathy is one of rare but devastating complication which may contribute to bleeding during and after TURP.
Although the exact pathophysiological condition of coagulopathy is not clear, there are several possible mechanisms of TURP associated coagulopathy including: urokinase- (u-PA) and tissue-type plasminogen activator (t-PA)-related fibrinolysis; absorption of irrigating fluid associated dilutional coagulopathy; release of prostatic particles rich in tissue thromboplastins into the circulation causing secondary fibrinolysis and disseminated intravascular coagulopathy (DIC); sepsis with DIC associated with bacteria entering the circulation due to prostatic venous sinuses opening and the using of high pressure irrigation.
On the other hand, platelet are essential to hemostasis and thrombosis and its activation also contributes to leukocyte recruitment and DIC.
Furthermore, previous studies demonstrated that activated platelets could express TLR4, CD40L, P-selectin and induce platelet-leukocyte aggregation (PLA), which were considered important for systemic inflammatory responses and DIC development.
Currently, no study investigating the association of prostate particle and platelet activation.
Here, we tested the hypothesis that prostate tissue may induce inflammatory responses through platelet activation by measuring the expression of TLR4, CD40L, P-selectin and PLA on platelets.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
8
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
40-80 year old male scheduled for transurethral resection of the prostate surgery.
Description
Inclusion Criteria:
- scheduled for TURP surgery
Exclusion Criteria:
- morbid obesity, bedridden, thromboembolic disease, sepsis, nephrotic syndrome, trauma, malignant tumor, disease associated with increasing blood viscosity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TLR4, CD40L and P-selectin expression
Time Frame: 2 hour, during surgical period
|
the expression of platelet activation markers by measuring the mean fluorescence intensity of CD40 ligand, Toll-like receptor 4, P-selectin on platelet surface
|
2 hour, during surgical period
|
|
Platelet leukocyte aggregation
Time Frame: 2 hour, during surgical period
|
measuring platelet-leukocyte aggregation by flow cytometry
|
2 hour, during surgical period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2015
Primary Completion (Actual)
April 24, 2017
Study Completion (Actual)
April 24, 2017
Study Registration Dates
First Submitted
September 19, 2021
First Submitted That Met QC Criteria
September 19, 2021
First Posted (Actual)
September 28, 2021
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 19, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-103-05-041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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