The Effect of Human Prostate Tissue on Platelet Activation

NCT05059431 | Completed DMC

• 1 other identifier: 2-103-05-041
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Hyperplasia; Coagulation; Intravascular; Thrombotic Disorder

Keywords

TURP; coagulopathy; DIC; thrombotic disorder

Outcome Measures

Primary Outcomes (2)

• TLR4, CD40L and P-selectin expression

  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

  measuring platelet-leukocyte aggregation by flow cytometry

  2 hour, during surgical period

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40-80 year old male scheduled for transurethral resection of the prostate surgery.

You may qualify if:

• scheduled for TURP surgery

You may not qualify if:

• morbid obesity, bedridden, thromboembolic disease, sepsis, nephrotic syndrome, trauma, malignant tumor, disease associated with increasing blood viscosity.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prostate tissue; blood sample

MeSH Terms

Conditions

Prostatic Hyperplasia; Thrombosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tri-Service General Hospital

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: September 28, 2021
• Study Start: February 4, 2015
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: September 28, 2021

Record last verified: 2021-09