Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT03822793
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRADO
Brief Summary:
A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.
Detailed Description:
This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: