Renal StonesNCT04367155
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
A study testing Tranexamic acid injection in people with Renal Stones and Nephrolithiasis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Stones, Nephrolithiasis
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Mar 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient 18 years or older
- Stones ≥ 2 cm and/or mild to moderate hydronephrosis.
Who cannot join
- Age <18 years or Pregnancy
- Bilateral simultaneous PCNL
- Morbid obesity (BMI >40)
- Refuse to complete study requirements
- Untreated UTI
- Atypical bowel interposition by CT
- Tumour in the presumptive access tract area or Potential malignant kidney tumour
Trial locations and contacts
1 site in 1 country.
Hossam Nabeeh, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh faculty of medicine
Kafr ash Shaykh, Kafrelsheikh
Diaa ELDIN Taha, MD, 01008531384, drdiaaeldin@gmail.com
Hossam Nabeeh, MD
About this study
Official title: Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.
Read the detailed description
To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.
- Conditions
- Renal Stones, Nephrolithiasis
- Being tested
- Tranexamic acid injection
- Keywords
- Tranexamic acid, percutanous nephrolithotomy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called tranexamic acid 500 mg
hemostatics use
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid local | Active comparator | tranexamic acid inside the irrigation fluid Receives: Drug: Tranexamic acid injection |
| tranexamic acid IV | Active comparator | tranexamic acid injection Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the value of tranexamic acid
To compare the efficacy and safety of 0.1% IV tranexamic acid versus inside the irrigant fluid tranexamic acid in reducing blood loss during PCNL. Moreover, to assess the adverse events of tranexamic acid.
Measured: 12 months
Secondary outcomes (2)
Hemoglobin drop post PCNL.
Assess fall percentage in hemoglobin drop.
Measured: 12 months
Requirement of blood transfusion post PCNL.
assess the total blood loss and requirement of blood transfusion post PCNL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Sep 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- tranexamic acid during and after percutanous nephrolithotomy procedure
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University
- Investigators
- Diaa Eldin Taha, MD, Principal investigator, Lecturer of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367155
- Sponsor's protocol ID
- RS/19.22
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cleveland B, Norling B, Wang H, Gandhi V, Price CL, Borofsky MS, Pais V, Dahm P. Tranexamic acid for percutaneous nephrolithotomy. Cochrane Database Syst Rev. 2023 Oct 26;10(10):CD015122. doi: 10.1002/14651858.CD015122.pub2.
PubMed 37882229
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04367155
- Acronym / sponsor ID
- RS/19.22
- Conditions
- Renal Stones, Nephrolithiasis
- Keywords
- Tranexamic acid, percutanous nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 29 Apr 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.
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.
Detailed description
To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- tranexamic acid during and after percutanous nephrolithotomy procedure
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid local | Active comparator | Drug: Tranexamic acid injectiontranexamic acid inside the irrigation fluid |
| tranexamic acid IV | Active comparator | Drug: Tranexamic acid injectiontranexamic acid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient 18 years or older
- Stones ≥ 2 cm and/or mild to moderate hydronephrosis.
Key exclusion criteria (7 listed)
- Age <18 years or Pregnancy
- Bilateral simultaneous PCNL
- Morbid obesity (BMI >40)
- Refuse to complete study requirements
- Untreated UTI
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 injectionAlso: tranexamic acid 500 mghemostatics use | Drug | tranexamic acid IV, tranexamic acid local |
Primary outcome
To assess the value of tranexamic acid
Time frame: 12 months
To compare the efficacy and safety of 0.1% IV tranexamic acid versus inside the irrigant fluid tranexamic acid in reducing blood loss during PCNL. Moreover, to assess the adverse events of tranexamic acid.
2 secondary outcomes
Hemoglobin drop post PCNL.
Time frame: 12 months
Requirement of blood transfusion post PCNL.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 37882229Cleveland B, Norling B, Wang H, Gandhi V, Price CL, Borofsky MS, Pais V, Dahm P. Tranexamic acid for percutaneous nephrolithotomy. Cochrane Database Syst Rev. 2023 Oct 26;10(10):CD015122. doi: 10.1002/14651858.CD015122.pub2.
- 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.
Hossam Nabeeh, MD contact
Diaa Eldin Taha, MD principal investigator
Lecturer of urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection in people with Renal Stones and Nephrolithiasis, run by Kafrelsheikh University at 1 site in Egypt.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diaa Eldin Taha, MD (01008531384, drdiaaeldin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the value of tranexamic acid (time frame: 12 months). 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 NCT04367155, which also lists 1 linked publication.
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 3 Mar 2021.