Recruiting

Tranexamic Acid

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT02738073

Conditions

Hip Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Control: Saline

Tranexamic Acid

Study Details

Brief summary:

Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.

Conditions

Hip Fracture

Study ID

NCT02738073

Status verified date

Apr, 2016

Primary completion date

Feb, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients admitted to Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.

Exclusion Criteria:

Exclusion criteria include

  • age under 18
  • allergy to TA
  • known current or history of venous thromboembolism (VTE)
  • history of known coagulopathy or bleeding disorder
  • current subarachnoid hemorrhage
  • previous history of seizures
  • current use of estrogen/progesterone therapy
  • renal failure defined as creatinine clearance less than 30 ml/min4
  • multiple fractures
  • pregnant or breastfeeding women
  • planned nonoperative management of the fracture

Study Design

Interventions and Outcome Measures

Arms

placebo comparator: Control

active comparator: Interventional

Interventions

Control: Saline

Tranexamic Acid

Primary outcome measure

  • calculation of blood loss during the perioperative period [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2-3 days ]

Central Contacts and Locations

Central contacts

Locations

Bryn Mawr Hospital

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Apr 14, 2016

Last verified

Apr, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2016-04-14.