Benign Prostatic HyperplasiaNCT02822963
Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate
An observational study of Benign Prostatic Hyperplasia and Prostate Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Prostate Cancer
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2016to Aug 2016
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male admitted to National Cheng Kung University Hospital for TURP.
Who may be able to join
- 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
Who cannot join
- Poor expression ability and without close care givers to answer questions
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Benign Prostatic Hyperplasia, Prostate Cancer
- Keywords
- Transurethral resection of the prostate, Anticoagulants, Platelet aggregation inhibitors
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood transfusion
Measured: in 1 week after surgery
Bladder clots
Measured: in 10 days after surgery
Hematuria
Measured: in 10 days after surgery
Urine tract infection
Measured: in 10 days after surgery
Duration of catheter
Measured: in 10 days after surgery
Duration of hospitalization
Measured: in 1 week after surgery
Cardiovascular event
Measured: In 28 days after surgery
Major bleeding
Measured: In 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822963
- Sponsor's protocol ID
- A-ER-105-045
- Status last verified
- Jun 2016
- First submitted
- 5 May 2016
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate
- ClinicalTrials.gov ID
- NCT02822963
- Acronym / sponsor ID
- A-ER-105-045
- Conditions
- Benign Prostatic Hyperplasia, Prostate Cancer
- Keywords
- Transurethral resection of the prostate, Anticoagulants, Platelet aggregation inhibitors
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male admitted to National Cheng Kung University Hospital for TURP.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Poor expression ability and without close care givers to answer questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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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 Benign Prostatic Hyperplasia and Prostate Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Oct 2020. 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 Taiwan. 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 was withdrawn before enrolling participants, so there are no results.
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?
Perioperative blood transfusion (time frame: in 1 week after surgery). The study lists 8 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 6 Oct 2020.