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Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02822963
Recruitment Status : Withdrawn (No funding)
First Posted : July 6, 2016
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Tracking Information
First Submitted Date May 5, 2016
First Posted Date July 6, 2016
Last Update Posted Date October 6, 2020
Study Start Date March 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2016)
  • Perioperative blood transfusion [ Time Frame: in 1 week after surgery ]
  • Bladder clots [ Time Frame: in 10 days after surgery ]
  • Hematuria [ Time Frame: in 10 days after surgery ]
  • Urine tract infection [ Time Frame: in 10 days after surgery ]
  • Duration of catheter [ Time Frame: in 10 days after surgery ]
  • Duration of hospitalization [ Time Frame: in 1 week after surgery ]
  • Cardiovascular event [ Time Frame: In 28 days after surgery ]
  • Major bleeding [ Time Frame: In 28 days after surgery ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate
Official Title Not Provided
Brief Summary Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP), is recommended. Although the procedure is quit safe, these old men often take anticoagulants and antiplatelets to control cardiovascular diseases, which arose some concerns for their bleeding risk. The management of anticoagulation in patients undergoing surgical procedures is challenging because interrupting anticoagulation increases the risk of thrombotic events. At the same time, surgery and invasive procedures have associated bleeding risks that are increased by the anticoagulant administration. Now, the recommendation about anticoagulants and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore, there is no relative studies done in Taiwan population, which calls for further investigation.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male admitted to National Cheng Kung University Hospital for TURP.
Condition
  • Benign Prostatic Hyperplasia
  • Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts
  • A
    Non anticoagulant and/or antiplatelet users.
  • B
    Anticoagulant and/or antiplatelet users that hold their drugs during perioperative periods.
  • C
    Anticoagulant and/or antiplatelet users that doesn't hold their drugs during perioperative periods.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: October 4, 2020)
0
Original Estimated Enrollment
 (submitted: June 30, 2016)
20
Estimated Study Completion Date August 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Admitted to National Cheng Kung University Hospital Urology during the study
  • Older than 20 years old
  • Agree to participate this study
  • Receiving transurethral resection of the prostate for benign prostatic hyperplasia or prostate cancer

Exclusion Criteria:

  • Poor expression ability and without close care givers to answer questions
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02822963
Other Study ID Numbers A-ER-105-045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Cheng-Kung University Hospital
Study Sponsor National Cheng-Kung University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Cheng-Kung University Hospital
Verification Date June 2016