NCT02966236

Brief Summary

This study is a double blinded randomized controlled trial evaluating the impact of tranexamic acid use on the transfusion rate in patients with complex kidney stones undergoing percutaneous nephrolithotomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

November 15, 2016

Last Update Submit

May 29, 2018

Conditions

NephrolithiasisStaghorn Calculus

Keywords

percutaneous nephrolithotomy

Outcome Measures

Primary Outcomes (1)

  • blood transfusion rate

    postoperative follow up

    two years

Secondary Outcomes (4)

  • blood loss

    two years

  • surgical time

    two years

  • stone free rate

    two years

  • complications

    two years

Study Arms (2)

Tranexamic Acid Group

EXPERIMENTAL

Tranexamic acid 1g IV during anesthesiology induction, single dose

Drug: Tranexamic Acid

Placebo group

PLACEBO COMPARATOR

normal saline 1g IV during anesthesiology induction, single dose

Drug: Placebos

Interventions

Tranexamic AcidDRUG
Tranexamic Acid Group
PlacebosDRUG
Placebo group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Complex kidney stone (staghorn calculi GUYS III and IV)

You may not qualify if:

  • Coronary artery disease - stent
  • Severe chronic renal failure
  • Congenital or acquired thrombophilia/thrombosis event
  • Known or suspected allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo Medical School

São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

  • Batagello CA, Vicentini FC, Monga M, Miller AW, Marchini GS, Torricelli FCM, Danilovic A, Coelho RF, Srougi M, Nahas WC, Mazzucchi E. Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomised, double-blinded, placebo-controlled trial. BJU Int. 2022 Jan;129(1):35-47. doi: 10.1111/bju.15378. Epub 2021 Jun 13.

    PMID: 33630393DERIVED

MeSH Terms

Conditions

NephrolithiasisStaghorn Calculi

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesKidney CalculiUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations

BR(1)