Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

Hip Fracture Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02738073
• Other study ID #: 14RGOOD01
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2014
• Last updated: April 8, 2016

Study information

• Verified date: April 2016
• Source: Rothman Institute Orthopaedics
• Contact: Tiffany Morrison, MS, CCRP
• Phone: 267-339-7818
• Email: tiffany.morrison[@]rothmaninstitute.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Control: Saline

• Tranexamic Acid

Locations

Country	Name	City	State
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calculation of blood loss during the perioperative period	This study aims to investigate the effect of tranexamic acid (TA) on blood loss and transfusion requirement during the perioperative period in patients who are admitted to the hospital with fracture of the hip and undergo surgical treatment. Both the drop in hemoglobin level from time of surgery (T0 being defined as just prior to surgery, while the patient waits in surgical holding area) over the subsequent several days, as well as post-operative transfusion rate, will be measured. The researchers' hypothesis is that both the hemoglobin drop and the subsequent transfusion requirement in patients who receive TA will be less than those who received saline placebo.	participants will be followed for the duration of hospital stay, an expected average of 2-3 days