Benign Prostatic HyperplasiaPhase 4TXA-AQNCT06710327
Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation
A Phase 4 study testing Tranexamic Acid (IV) in people with Benign Prostatic Hyperplasia, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tranexamic Acid (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants diagnosed with BPH scheduled for Aquablation therapy.
- Aged 45 years or older
- Exhibiting clinically significant symptoms of BPH.
Who cannot join
- History of or high risk for thrombosis.
- Presence of preoperative heart or cerebrovascular diseases.
- Renal insufficiency.
- Ongoing anticoagulation therapy.
- Required extended preoperative resting period.
- Diagnosis of prostate cancer.
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- Any form of blood coagulation dysfunction.
- Previous use of warfarin or aspirin before the surgery.
- Belonging to vulnerable populations such as prisoners (who are not treated in our clinics).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Christopher F Tenggardjaja, MD, 323-783-0397, Christopher.Tenggardjaja@kp.org
Eric J Robinson, MD, 323-387-6121, Eric.J.Robinson@kp.org
About this study
Official title: Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation for Benign Prostatic Hyperplasia: a Randomized Controlled Trial
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). BPH is a common condition in men over the age of 45 that involves enlargement of the prostate gland and can lead to problems or discomfort with urination.
The main goal of this research is to see if TXA can help reduce the amount of blood loss during surgery compared to not using the drug. This is important because losing less blood during surgery can help patients recover faster and more safely. Researchers will monitor the safety of TXA and its effects on other outcomes, like the length of hospital stay and any possible changes in blood tests that check how well blood clots.
Read more
Participants in this study will:
- Be males diagnosed with BPH who are already scheduled to undergo Aquablation therapy.
- Be randomly assigned to either receive TXA or a placebo (a look-alike substance that contains no drug) right before their surgery.
- Not know which treatment they are receiving to make sure the results are unbiased.
Researchers hope to engage participants who meet the health criteria of the study. They will be carefully monitored before, during, and after the surgery for any health changes, and their blood loss during surgery will be measured.
This study does not require any additional time commitment outside of the standard surgical process, and all treatments will be provided at no additional cost to the participants. The researchers will ensure that all participants understand the procedure and support their safety throughout the research.
Read the detailed description
This clinical study is investigating whether a medication called tranexamic acid (TXA) can help reduce blood loss during a type of prostate surgery known as Aquablation therapy. This therapy is used to treat Benign Prostatic Hyperplasia (BPH), a common condition in older men that results in the enlargement of the prostate gland which can cause difficulty with urination.
Purpose of the Study:
The primary purpose of this research is to determine if TXA makes this surgery safer by decreasing the amount of blood lost during the procedure. Reducing blood loss during surgery is beneficial because it can lead to quicker recovery times and reduce the likelihood of complications. The study will also look at other important factors such as the overall safety of using TXA, its effect on the length of time participants stay in the hospital after surgery, and whether it causes any significant changes in blood clotting tests.
How the Research Will Happen:
Participants in the study will be men diagnosed with BPH who are planning to undergo Aquablation therapy. They will be randomly placed into one of two groups:
One group will receive TXA through an IV right before their surgery. The other group will receive a placebo, which is a substance that looks like the medication but contains no active drug, administered in the same way.
This setup ensures that neither the participants nor the health care providers know who receives the TXA and who receives the placebo, helping to maintain objectivity in the results.
What Participants Will Do:
Participants will visit the hospital as they normally would for their scheduled surgery. Before the surgery, they will receive either TXA or the placebo. The procedure itself and the immediate recovery process do not change. Researchers will collect information about how much blood participants lose during surgery and monitor their recovery closely.
The number of visits and what each participant needs to do during the study remains the same as what would happen during typical Aquablation therapy. Besides receiving the TXA or placebo, there are no additional procedures or drugs involved.
Safety Measures:
Study researchers are committed to participant safety. Participants will be closely monitored throughout the surgery and their recovery. The research team will watch for any side effects or reactions to the medication, especially any signs of blood clotting or allergic reactions, as TXA is known to affect blood clotting. If there are any concerns about a participant's health, they can be quickly addressed by the medical team.
Why This Matters:
For men undergoing Aquablation therapy for BPH, managing blood loss is a major safety concern. If TXA can effectively reduce blood loss without causing other complications, it could improve the outcomes for thousands of men who undergo this surgery every year.
This study will help doctors better understand the benefits and risks of using TXA in this setting, potentially leading to its wider use in similar surgeries to improve patient safety and outcomes.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tranexamic Acid (IV), Placebo
- Keywords
- BPH, TXA, Aquablation, Benign Prostatic Hyperplasia, Tranexamic Acid
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (IV)Drug
Also called TXA, Cyclokapron
The intervention is administered as a clear, colorless solution infusion. The dosage administered is a 1 gram intravenous (IV) push, delivered immediately before starting the Aquablation therapy. The administration of TXA occurs only once, as a single dose preoperatively.
PlaceboDrug
Also called normal saline, NS
Participants receive a saline solution, which is a sodium chloride (0.9%) IV infusion, identical in appearance to the TXA solution. The saline is administered as a single 1 gram-equivalent volume intravenous (IV) push, delivered immediately before the Aquablation therapy commences. This singular administration matches the frequency and timing of the TXA intervention to ensure uniformity across both study groups, maintaining the blinding of the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive an intravenous (IV) administration of a placebo prior to their Aquablation procedure. This placebo is a saline solution that looks identical to the tranexamic acid (TXA) used in the Intervention Group but contains no active medication. The placebo is given to mimic the administration of TXA to ensure that the study conditions are the same for both groups, except for the active treatment. All other aspects of the surgical procedure and postoperative care remaining standardized across both study arms. Receives: Drug: Placebo |
| TXA Administration | Experimental | Participants receive tranexamic acid (TXA) preoperatively via intravenous (IV) administration. The dose consists of 1g of TXA delivered in a single IV push immediately prior to the Aquablation therapy. TXA acts as an antifibrinolytic agent, preventing excessive blood loss by stabilizing the formation of blood clots during surgery. This intervention aims to assess TXA's efficacy in reducing perioperative blood loss compared to placebo, with all other aspects of the surgical procedure and postoperative care remaining standardized across both study arms. Receives: Drug: Tranexamic Acid (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Hemoglobin Change
The primary outcome measure is the efficacy of tranexamic acid (TXA) in decreasing the amount of hemoglobin lost during Aquablation therapy compared to placebo. This will be quantitatively assessed by measuring the hemoglobin levels in patients' blood samples collected immediately before and after the procedure. The change in hemoglobin levels will be compared between the TXA-treated group and the placebo group to determine if TXA administration results in a significantly smaller decrease in hemoglobin, indicating less blood loss.
Measured: Measured preoperatively and postoperatively, within 2 hours of surgery completion
Secondary outcomes (5)
Rate of Perioperative Complications Associated with Tranexamic Acid
This measure tracks the incidence of perioperative complications, including but not limited to thromboembolic events, which are potential risks associated with TXA. The frequency of these complications will be compared between patients treated with TXA and those receiving a placebo to understand any increased risks when using TXA in the context of Aquablation therapy.
Measured: From initiation of surgery to post-operative follow up, up to 60 days post-surgery.
Length of Hospital Stay Post-Aquablation Therapy
This secondary outcome evaluates whether TXA administration affects the length of postoperative hospital stay compared to placebo. The length of stay is calculated from the time of surgery completion to the time of discharge, aiming to ascertain if TXA can contribute to a faster recovery and shorter hospitalization.
Measured: From time of surgery to hospital discharge, typically within 1 day post-surgery
Change in ProThrombin Time (PT) Following Tranexamic Acid Administration
This measure determines if TXA administration has any significant effect on an element of the coagulation, prothrombin time (PT). Serum sample will be collected and analyzed preoperatively and postoperatively to detect any changes that might indicate a heightened risk of clotting or bleeding abnormalities.
Measured: Lab values measured preoperatively and within 2 hours post-surgery.
Change in activated partial thromboplastin time (aPTT) Following Tranexamic Acid Administration
This measure determines if TXA administration has any significant effect on an element of the coagulation, activated partial thromboplastin time (aPTT). Serum sample will be collected and analyzed preoperatively and postoperatively to detect any changes that might indicate a heightened risk of clotting or bleeding abnormalities.
Measured: Lab values measured preoperatively and within 2 hours post-surgery.
Change in activated fibrinogen level Following Tranexamic Acid Administration
This measure determines if TXA administration has any significant effect on an element of the coagulation and platelet activity, fibrinogen. Serum sample will be collected and analyzed preoperatively and postoperatively to detect any changes that might indicate a heightened risk of clotting or bleeding abnormalities.
Measured: Lab values measured preoperatively and within 2 hours post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
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 Kaiser PermanenteThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher F Tenggardjaja, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710327
- Sponsor's protocol ID
- KPSC IRB 056236
- Other IDs
- KPSC IRB 056263
- Acronym
- TXA-AQ
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data from this study will not be shared publicly due to concerns regarding participant privacy and confidentiality. The sensitivity of the health information collected, especially in a clinical trial context, requires strict adherence to privacy protections. Disclosure risks associated with sharing detailed IPD can potentially lead to identification of participants, despite data anonymization procedures. Furthermore, the consent forms participants will sign at the beginning of the trial include clauses that specifically limit the use of their data to the researchers involved in this study and for the purpose of assessing the efficacy and safety of tranexamic acid in this specific surgical setting. As such, participants will not be consented to broader data sharing with the public or external entities.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation for Benign Prostatic Hyperplasia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06710327
- Acronym / sponsor ID
- TXA-AQ / KPSC IRB 056236
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, TXA, Aquablation, Benign Prostatic Hyperplasia, Tranexamic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Nov 2024 (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.
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). BPH is a common condition in men over the age of 45 that involves enlargement of the prostate gland and can lead to problems or discomfort with urination.
The main goal of this research is to see if TXA can help reduce the amount of blood loss during surgery compared to not using the drug. This is important because losing less blood during surgery can help patients recover faster and more safely. Researchers will monitor the safety of TXA and its effects on other outcomes, like the length of hospital stay and any possible changes in blood tests that check how well blood clots.
Participants in this study will:
- Be males diagnosed with BPH who are already scheduled to undergo Aquablation therapy.
- Be randomly assigned to either receive TXA or a placebo (a look-alike substance that contains no drug) right before their surgery.
- Not know which treatment they are receiving to make sure the results are unbiased.
Researchers hope to engage participants who meet the health criteria of the study. They will be carefully monitored before, during, and after the surgery for any health changes, and their blood loss during surgery will be measured.
This study does not require any additional time commitment outside of the standard surgical process, and all treatments will be provided at no additional cost to the participants. The researchers will ensure that all participants understand the procedure and support their safety throughout the research.
Detailed description
This clinical study is investigating whether a medication called tranexamic acid (TXA) can help reduce blood loss during a type of prostate surgery known as Aquablation therapy. This therapy is used to treat Benign Prostatic Hyperplasia (BPH), a common condition in older men that results in the enlargement of the prostate gland which can cause difficulty with urination.
Purpose of the Study:
The primary purpose of this research is to determine if TXA makes this surgery safer by decreasing the amount of blood lost during the procedure. Reducing blood loss during surgery is beneficial because it can lead to quicker recovery times and reduce the likelihood of complications. The study will also look at other important factors such as the overall safety of using TXA, its effect on the length of time participants stay in the hospital after surgery, and whether it causes any significant changes in blood clotting tests.
How the Research Will Happen:
Participants in the study will be men diagnosed with BPH who are planning to undergo Aquablation therapy. They will be randomly placed into one of two groups:
One group will receive TXA through an IV right before their surgery. The other group will receive a placebo, which is a substance that looks like the medication but contains no active drug, administered in the same way.
This setup ensures that neither the participants nor the health care providers know who receives the TXA and who receives the placebo, helping to maintain objectivity in the results.
What Participants Will Do:
Participants will visit the hospital as they normally would for their scheduled surgery. Before the surgery, they will receive either TXA or the placebo. The procedure itself and the immediate recovery process do not change. Researchers will collect information about how much blood participants lose during surgery and monitor their recovery closely.
The number of visits and what each participant needs to do during the study remains the same as what would happen during typical Aquablation therapy. Besides receiving the TXA or placebo, there are no additional procedures or drugs involved.
Safety Measures:
Study researchers are committed to participant safety. Participants will be closely monitored throughout the surgery and their recovery. The research team will watch for any side effects or reactions to the medication, especially any signs of blood clotting or allergic reactions, as TXA is known to affect blood clotting. If there are any concerns about a participant's health, they can be quickly addressed by the medical team.
Why This Matters:
For men undergoing Aquablation therapy for BPH, managing blood loss is a major safety concern. If TXA can effectively reduce blood loss without causing other complications, it could improve the outcomes for thousands of men who undergo this surgery every year.
This study will help doctors better understand the benefits and risks of using TXA in this setting, potentially leading to its wider use in similar surgeries to improve patient safety and outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive an intravenous (IV) administration of a placebo prior to their Aquablation procedure. This placebo is a saline solution that looks identical to the tranexamic acid (TXA) used in the Intervention Group but contains no active medication. The placebo is given to mimic the administration of TXA to ensure that the study conditions are the same for both groups, except for the active treatment. All other aspects of the surgical procedure and postoperative care remaining standardized across both study arms. |
| TXA Administration | Experimental | Drug: Tranexamic Acid (IV)Participants receive tranexamic acid (TXA) preoperatively via intravenous (IV) administration. The dose consists of 1g of TXA delivered in a single IV push immediately prior to the Aquablation therapy. TXA acts as an antifibrinolytic agent, preventing excessive blood loss by stabilizing the formation of blood clots during surgery. This intervention aims to assess TXA's efficacy in reducing perioperative blood loss compared to placebo, with all other aspects of the surgical procedure and postoperative care remaining standardized across both study arms. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male participants diagnosed with BPH scheduled for Aquablation therapy.
- Aged 45 years or older
- Exhibiting clinically significant symptoms of BPH.
Key exclusion criteria (9 listed)
- History of or high risk for thrombosis.
- Presence of preoperative heart or cerebrovascular diseases.
- Renal insufficiency.
- Ongoing anticoagulation therapy.
- Required extended preoperative resting period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (IV)Also: TXA, CyclokapronThe intervention is administered as a clear, colorless solution infusion. The dosage administered is a 1 gram intravenous (IV) push, delivered immediately before starting the Aquablation therapy. The administration of TXA occurs only once, as a single dose preoperatively. | Drug | TXA Administration |
| PlaceboAlso: normal saline, NSParticipants receive a saline solution, which is a sodium chloride (0.9%) IV infusion, identical in appearance to the TXA solution. The saline is administered as a single 1 gram-equivalent volume intravenous (IV) push, delivered immediately before the Aquablation therapy commences. This singular administration matches the frequency and timing of the TXA intervention to ensure uniformity across both study groups, maintaining the blinding of the study. | Drug | Placebo |
Primary outcome
Perioperative Hemoglobin Change
Time frame: Measured preoperatively and postoperatively, within 2 hours of surgery completion
The primary outcome measure is the efficacy of tranexamic acid (TXA) in decreasing the amount of hemoglobin lost during Aquablation therapy compared to placebo. This will be quantitatively assessed by measuring the hemoglobin levels in patients' blood samples collected immediately before and after the procedure. The change in hemoglobin levels will be compared between the TXA-treated group and the placebo group to determine if TXA administration results in a significantly smaller decrease in hemoglobin, indicating less blood loss.
5 secondary outcomes
Rate of Perioperative Complications Associated with Tranexamic Acid
Time frame: From initiation of surgery to post-operative follow up, up to 60 days post-surgery.
Length of Hospital Stay Post-Aquablation Therapy
Time frame: From time of surgery to hospital discharge, typically within 1 day post-surgery
Change in ProThrombin Time (PT) Following Tranexamic Acid Administration
Time frame: Lab values measured preoperatively and within 2 hours post-surgery.
Change in activated partial thromboplastin time (aPTT) Following Tranexamic Acid Administration
Time frame: Lab values measured preoperatively and within 2 hours post-surgery.
Change in activated fibrinogen level Following Tranexamic Acid Administration
Time frame: Lab values measured preoperatively and within 2 hours post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No. Individual participant data from this study will not be shared publicly due to concerns regarding participant privacy and confidentiality. The sensitivity of the health information collected, especially in a clinical trial context, requires strict adherence to privacy protections. Disclosure risks associated with sharing detailed IPD can potentially lead to identification of participants, despite data anonymization procedures. Furthermore, the consent forms participants will sign at the beginning of the trial include clauses that specifically limit the use of their data to the researchers involved in this study and for the purpose of assessing the efficacy and safety of tranexamic acid in this specific surgical setting. As such, participants will not be consented to broader data sharing with the public or external entities.
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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.
Christopher F Tenggardjaja, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (IV) in people with Benign Prostatic Hyperplasia, run by Kaiser Permanente at 1 site in United States.
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 9 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: opening soon, as of the sponsor's last update on 29 Nov 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher F Tenggardjaja, MD (323-783-0397, Christopher.Tenggardjaja@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Hemoglobin Change (time frame: Measured preoperatively and postoperatively, within 2 hours of surgery completion). 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 29 Nov 2024.