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Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? (RARPEX)

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ClinicalTrials.gov Identifier: NCT04319614
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Michal Balik, University Hospital Hradec Kralove

Study Description
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Brief 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. 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 December 2021. The patients will be randomly assigned to study and control groups of 100 patients each. The minimum follow-up will be 3 months.


Condition or disease Intervention/treatment Phase
Robotic-assisted Radical Prostatectomy Drug: Tranexamic Acid Injectable Product Drug: Placebos Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tranexamic acid Drug: Tranexamic Acid Injectable Product
A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.
Placebo Comparator: Saline Drug: Placebos
100 ml of saline will be administered in the beginning of the procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of blood loss [ Time Frame: 7 days after the procedure ]
    The drop of hemoglobin level, weighted on gram of prostate or creatinin level.


Secondary Outcome Measures :
  1. The risk of postoperative complications [ Time Frame: 90 days after the procedure ]
    The incidence and severity of postoperative complications according to Dindo/Clavien Classification.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients with prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319614


Contacts
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Contact: Michal Balik, MD +420605544049 michal.balik@fnhk.cz
Contact: Pavel Navratil jr., MD pavel.navratil2@fnhk.cz

Locations
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Czechia
University Hospital Hradec Králové Recruiting
Hradec Králové, Czechia, 50005
Contact: Michal Balik, PI    +420605544049    michal.balik@fnhk.cz   
Contact: Pavel Navratil, SI    +420603165352    pavel.nevratil2@fnhk.cz   
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
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Study Chair: Milos Brodak, Prof.MD, PhD. University Hospital Hradec Kralove
Principal Investigator: Michal Balik, MD University Hospital Hradec Kralove
More Information
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Responsible Party: Michal Balik, Principal Investigator, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT04319614    
Other Study ID Numbers: RARPEX
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michal Balik, University Hospital Hradec Kralove:
Tranexamic acid
robotic assisted radical prostatectomy
bleeding prophylaxis
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants