Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

NCT ID: NCT04367155

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-03-01

Brief Summary

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Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.

Detailed Description

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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

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Renal Stones Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

tranexamic acid during and after percutanous nephrolithotomy procedure
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
randomization

Study Groups

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tranexamic acid local

tranexamic acid inside the irrigation fluid

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

hemostatics use

tranexamic acid IV

tranexamic acid injection

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

hemostatics use

Interventions

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Tranexamic acid injection

hemostatics use

Intervention Type DRUG

Other Intervention Names

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tranexamic acid 500 mg

Eligibility Criteria

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Inclusion Criteria

* Patient 18 years or older
* Stones ≥ 2 cm and/or mild to moderate hydronephrosis.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Diaa Eldin Taha Ramadan Mohamed

Lecturer of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diaa Eldin Taha, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of urology

Locations

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Kafrelsheikh faculty of medicine

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Diaa Eldin Taha, MD

Role: CONTACT

01008531384

Hossam Nabeeh, MD

Role: CONTACT

Facility Contacts

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Diaa ELDIN Taha, MD

Role: primary

01008531384

References

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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.

Reference Type DERIVED
PMID: 37882229 (View on PubMed)

Other Identifiers

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RS/19.22

Identifier Type: -

Identifier Source: org_study_id

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