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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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||
100 ml of saline will be administered in the beginning of the procedure.
- Reduction of blood loss [ Time Frame: 7 days after the procedure ]The drop of hemoglobin level, weighted on gram of prostate or creatinin level.
- The risk of postoperative complications [ Time Frame: 90 days after the procedure ]The incidence and severity of postoperative complications according to Dindo/Clavien Classification.
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
|Contact: Michal Balik, MDfirstname.lastname@example.org|
|Contact: Pavel Navratil jr., MDemail@example.com|
|Study Chair:||Milos Brodak, Prof.MD, PhD.||University Hospital Hradec Kralove|
|Principal Investigator:||Michal Balik, MD||University Hospital Hradec Kralove|