Clinical Trials Directory

Trials / Terminated

TerminatedNCT01866943

Role of Topical Tranexamic Acid in Total Hip Arthroplasty

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
41 (actual)
Sponsor
Northwell Health · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Conditions

Interventions

TypeNameDescription
DRUGTranexamic AcidTranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
DRUGNormal Saline Solution

Timeline

Start date
2011-11-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2013-06-03
Last updated
2018-03-13
Results posted
2018-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01866943. Inclusion in this directory is not an endorsement.