Robotic-assisted Radical ProstatectomyPhase 4RARPEXNCT04319614
Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy?
A Phase 4 study testing Tranexamic Acid Injectable Product in people with Robotic-assisted Radical Prostatectomy, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirm this finding. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Robotic-assisted Radical Prostatectomy
- What is being tested?
- Tranexamic Acid Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 24 Feb 2020to 30 Jun 2022
- Phase
- Phase 4
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for robotic-assisted radical prostatectomy without pelvic lymph node dissection
- Signed informed consent provided
- Body mass index ≤ 35
- Age of the patient ≤ 75 years
- Operating surgeon with experience > 100 cases
Who cannot join
- Body mass index > 35
- Age of the patient > 75 years
- Coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants)
- Thromboembolic, cerebral, or an acute coronary event within the 6 months prior to prostatectomy
- Chronic renal insufficiency (arbitrary cut-off level of creatinine 200 μmol/l)
- Allergic reaction to tranexamic acid
- Operating surgeon with experience < 100 cases
- Participation in other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? The RARPEX (Robotic Assisted Radical Prostatectomy With TranEXamic Acid) Study.
The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirm this finding. The aim of this study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and incidence and severity of postoperative complications. A prospective, double-blind, randomized study is conducted to evaluate the effect on several parameters.
Based on pilot study data the investigators decided to include 200 patients in the period from February 2020 to March 2022. The patients will be randomly assigned to study and control groups of 100 patients each. The minimum follow-up will be 3 months.
Read the detailed description
Prostate adenocarcinoma is the second most common malignancy and the second most common cause of death due to malignancy in men. Standard treatment includes radical prostatectomy or radiotherapy in patients with life expectancy for more than 10 years. In recent years, a general tendency toward minimally invasive surgical procedures has been seen. Despite tremendous development in the technology and technique of robotic-assisted radical prostatectomy for more than 25 years, there is still need to look for ways to improve oncological and functional outcomes. Decreasing peri- and postoperative blood loss may lead to faster recovery after the procedure.
Tranexamic acid is an antifibrinolytic used to relieve bleeding. The mechanism of action lies in binding to plasma free plasminogen with higher affinity than tissue plasminogen activator. It prevents its conversion to plasmin, which is responsible for the degradation of fibrin polymers. It results in greater stability of the fibrin clot at the site of bleeding and, therefore, lower blood loss. The use of tranexamic acid during or after the operation does not improve results, unlike administration prior to surgery and the dorsal complex vein is sutured in the beginning of the procedure.
This study is designed to answer the question of whether it might lower the drop in hemoglobin level after the procedure or increase the rate and severity of complications.
This trial was approved by the independent ethics committee at the University Hospital Hradec Kralove (registration number 201903 I90P).
- Conditions
- Robotic-assisted Radical Prostatectomy
- Being tested
- Tranexamic Acid Injectable Product, Placebos
- Keywords
- Tranexamic acid, robotic assisted radical prostatectomy, bleeding prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injectable ProductDrug
A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.
PlacebosDrug
100 ml of saline will be administered in the beginning of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic Acid Injectable Product |
| Saline | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of blood loss
The drop of hemoglobin level, weighted on gram of prostate or creatinin level.
Measured: 7 days after the procedure
Secondary outcomes (1)
The risk of postoperative complications
The incidence and severity of postoperative complications according to Dindo/Clavien Classification.
Measured: 90 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start24 Feb 2020
- Primary completion12 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Robotic-assisted Radical ProstatectomyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Balik, University Hospital Hradec Kralove
- Investigators
- Milos Brodak, Prof.MD, PhD., Study chair, University Hospital Hradec KraloveMichal Balik, MD, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319614
- Sponsor's protocol ID
- RARPEX
- Acronym
- RARPEX
- Status last verified
- Nov 2022
- First submitted
- 20 Mar 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balik M, Kosina J, Husek P, Brodak M, Cecka F. Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study. Acta Medica (Hradec Kralove). 2020;63(4):176-182. doi: 10.14712/18059694.2020.60.
PubMed 33355078Balik M, Kosina J, Husek P, Pacovsky J, Brodak M, Cecka F. Can the prophylactic administration of tranexamic acid reduce the blood loss after robotic-assisted radical prostatectomy? Robotic Assisted Radical Prostatectomy with tranEXamic acid (RARPEX): study protocol for a randomized controlled trial. Trials. 2022 Jun 18;23(1):508. doi: 10.1186/s13063-022-06447-x.
PubMed 35717263
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? The RARPEX (Robotic Assisted Radical Prostatectomy With TranEXamic Acid) Study.
- ClinicalTrials.gov ID
- NCT04319614
- Acronym / sponsor ID
- RARPEX / RARPEX
- Conditions
- Robotic-assisted Radical Prostatectomy
- Keywords
- Tranexamic acid, robotic assisted radical prostatectomy, bleeding prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Mar 2020 (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.
The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirm this finding. The aim of this study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and incidence and severity of postoperative complications. A prospective, double-blind, randomized study is conducted to evaluate the effect on several parameters.
Based on pilot study data the investigators decided to include 200 patients in the period from February 2020 to March 2022. The patients will be randomly assigned to study and control groups of 100 patients each. The minimum follow-up will be 3 months.
Detailed description
Prostate adenocarcinoma is the second most common malignancy and the second most common cause of death due to malignancy in men. Standard treatment includes radical prostatectomy or radiotherapy in patients with life expectancy for more than 10 years. In recent years, a general tendency toward minimally invasive surgical procedures has been seen. Despite tremendous development in the technology and technique of robotic-assisted radical prostatectomy for more than 25 years, there is still need to look for ways to improve oncological and functional outcomes. Decreasing peri- and postoperative blood loss may lead to faster recovery after the procedure.
Tranexamic acid is an antifibrinolytic used to relieve bleeding. The mechanism of action lies in binding to plasma free plasminogen with higher affinity than tissue plasminogen activator. It prevents its conversion to plasmin, which is responsible for the degradation of fibrin polymers. It results in greater stability of the fibrin clot at the site of bleeding and, therefore, lower blood loss. The use of tranexamic acid during or after the operation does not improve results, unlike administration prior to surgery and the dorsal complex vein is sutured in the beginning of the procedure.
This study is designed to answer the question of whether it might lower the drop in hemoglobin level after the procedure or increase the rate and severity of complications.
This trial was approved by the independent ethics committee at the University Hospital Hradec Kralove (registration number 201903 I90P).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid Injectable Product |
| Saline | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for robotic-assisted radical prostatectomy without pelvic lymph node dissection
- Signed informed consent provided
- Body mass index ≤ 35
- Age of the patient ≤ 75 years
- Operating surgeon with experience > 100 cases
Key exclusion criteria (8 listed)
- Body mass index > 35
- Age of the patient > 75 years
- Coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants)
- Thromboembolic, cerebral, or an acute coronary event within the 6 months prior to prostatectomy
- Chronic renal insufficiency (arbitrary cut-off level of creatinine 200 μmol/l)
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 Injectable ProductA single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure. | Drug | Tranexamic acid |
| Placebos100 ml of saline will be administered in the beginning of the procedure. | Drug | Saline |
Primary outcome
Reduction of blood loss
Time frame: 7 days after the procedure
The drop of hemoglobin level, weighted on gram of prostate or creatinin level.
1 secondary outcome
The risk of postoperative complications
Time frame: 90 days after the procedure
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 9 Nov 2022.
- Background: PubMed 33355078Balik M, Kosina J, Husek P, Brodak M, Cecka F. Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study. Acta Medica (Hradec Kralove). 2020;63(4):176-182. doi: 10.14712/18059694.2020.60.
- Background: PubMed 35717263Balik M, Kosina J, Husek P, Pacovsky J, Brodak M, Cecka F. Can the prophylactic administration of tranexamic acid reduce the blood loss after robotic-assisted radical prostatectomy? Robotic Assisted Radical Prostatectomy with tranEXamic acid (RARPEX): study protocol for a randomized controlled trial. Trials. 2022 Jun 18;23(1):508. doi: 10.1186/s13063-022-06447-x.
- Individual participant dataSharing planned: No
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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.
Milos Brodak, Prof.MD, PhD. study chair
University Hospital Hradec Kralove
Michal Balik, MD principal investigator
University Hospital Hradec Kralove
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 Injectable Product in people with Robotic-assisted Radical Prostatectomy, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 5 inclusion and 8 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 9 Nov 2022. 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 Czechia. 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?
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?
Reduction of blood loss (time frame: 7 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319614, which also lists 2 linked publications.
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 9 Nov 2022.