HematuriaNCT05314582
Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia
An observational study of Hematuria and Retention, Urinary, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematuria, Retention, Urinary, Operative Bleeding
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 10 Jan 2023
- How long will I take part?
- 1 Month
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were referred to endoscopic bladder tumor resection (TUR-BT) or open or endoscopic BPH surgery (TURP or open prostatectomy) will be included in this study. For patients using anticoagulant/antiaggregant medications, relevant specialty (eg: Cardiology, neurology, cardiovascular surgery) or anesthesiologist will decide whether the patient will quit these medications before surgery or not, when to quit and whether low molecular weight heparin will be started instead. The responsible physician of the patient will decide when to restart the anticoagulant therapy after the surgery.
Who may be able to join
- Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer
- Patients undergoing TURP due to benign prostatic hyperplasia
- Patients undergoing open prostatectomy due to benign prostatic hyperplasia
Who cannot join
- Patients who underwent incomplete transurethral tumor resection for bladder cancer
- Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion
- Patients who underwent cystectomy for bladder cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia
Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared.
- Keywords
- bladder cancer, benign prostatic hyperplasia, transurethral resection, hematuria
- Medical subject headings
- Hematuria, Urinary Retention, Transfusion Reaction, Urinary Bladder Neoplasms, Prostatic Hyperplasia
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 |
|---|---|---|
| TURP patients using anticoagulant/antiaggregant medication | Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic prostatectomy (TURP). | |
| TURP patients not using anticoagulant/antiaggregant medication | Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic prostatectomy (TURP). | |
| TUR-BT patients using anticoagulant/antiaggregant medication | Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic bladder tumor resection (TUR-BT). | |
| TUR-BT patients not using anticoagulant/antiaggregant medication | Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic bladder tumor resection (TUR-BT). | |
| Open prostatectomy patients using anticoagulant/antiaggregant medication | Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent open prostatectomy (OP). | |
| Open prostatectomy patients not using anticoagulant/antiaggregant medication | Patients with no history of anticoagulant/antiaggregant medication and underwent open prostatectomy (OP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episode of clot retention
Presence of clot retention due to hematuria after the operation which requires manuel irrigation
Measured: Immediately after the surgery up to 1 month
Requirement of blood transfusion
Gross hematuria requiring blood transfusion
Measured: Immediately after the surgery up to 1 month
Re-operation rates
Re-operation requirement for hematuria
Measured: Immediately after the surgery up to 1 month
Duration of hospitalization
Duration of hospitalization
Measured: Immediately after the surgery up to discharge
Rate of re-admission
Rate of re-admission due to hematuria
Measured: From discharge up to one month
Secondary outcomes (2)
Postoperative hematocrit/hemoglobin levels
Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.
Measured: Immediately after the surgery up to discharge
Amount of irrigation volume
Amount of postoperative continuous bladder irrigation volume
Measured: Immediately after the surgery up to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start10 Mar 2022
- Primary completion10 Dec 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah İlktaç, Bezmialem Vakif University
- Investigators
- Abdullah Ilktac, MD, Study chair, Bezmialem Vakif University, Faculty of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314582
- Sponsor's protocol ID
- 196083
- Status last verified
- Jul 2023
- First submitted
- 27 Mar 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05314582
- Acronym / sponsor ID
- 196083
- Keywords
- bladder cancer, benign prostatic hyperplasia, transurethral resection, hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 6 Apr 2022 (actual)
- 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.
Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TURP patients using anticoagulant/antiaggregant medication | – | –Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic prostatectomy (TURP). |
| TURP patients not using anticoagulant/antiaggregant medication | – | –Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic prostatectomy (TURP). |
| TUR-BT patients using anticoagulant/antiaggregant medication | – | –Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic bladder tumor resection (TUR-BT). |
| TUR-BT patients not using anticoagulant/antiaggregant medication | – | –Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic bladder tumor resection (TUR-BT). |
| Open prostatectomy patients using anticoagulant/antiaggregant medication | – | –Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent open prostatectomy (OP). |
| Open prostatectomy patients not using anticoagulant/antiaggregant medication | – | –Patients with no history of anticoagulant/antiaggregant medication and underwent open prostatectomy (OP). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were referred to endoscopic bladder tumor resection (TUR-BT) or open or endoscopic BPH surgery (TURP or open prostatectomy) will be included in this study. For patients using anticoagulant/antiaggregant medications, relevant specialty (eg: Cardiology, neurology, cardiovascular surgery) or anesthesiologist will decide whether the patient will quit these medications before surgery or not, when to quit and whether low molecular weight heparin will be started instead. The responsible physician of the patient will decide when to restart the anticoagulant therapy after the surgery.
Key inclusion criteria (3 listed)
- Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer
- Patients undergoing TURP due to benign prostatic hyperplasia
- Patients undergoing open prostatectomy due to benign prostatic hyperplasia
Key exclusion criteria (3 listed)
- Patients who underwent incomplete transurethral tumor resection for bladder cancer
- Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion
- Patients who underwent cystectomy for bladder cancer
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
Episode of clot retention
Time frame: Immediately after the surgery up to 1 month
Presence of clot retention due to hematuria after the operation which requires manuel irrigation
Requirement of blood transfusion
Time frame: Immediately after the surgery up to 1 month
Gross hematuria requiring blood transfusion
Re-operation rates
Time frame: Immediately after the surgery up to 1 month
Re-operation requirement for hematuria
Duration of hospitalization
Time frame: Immediately after the surgery up to discharge
Duration of hospitalization
Rate of re-admission
Time frame: From discharge up to one month
Rate of re-admission due to hematuria
2 secondary outcomes
Postoperative hematocrit/hemoglobin levels
Time frame: Immediately after the surgery up to discharge
Amount of irrigation volume
Time frame: Immediately after the surgery up to discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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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.
Abdullah Ilktac, MD study chair
Bezmialem Vakif University, Faculty of Medicine, Department of Urology
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 Hematuria and Retention, Urinary, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 2023. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Episode of clot retention (time frame: Immediately after the surgery up to 1 month). The study lists 5 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 28 Jul 2023.