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

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ClinicalTrials.gov Identifier: NCT02738073
Recruitment Status : Unknown
Verified April 2016 by Rothman Institute Orthopaedics.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Drug: Control: Saline Drug: Tranexamic Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Primary Completion Date : February 2017

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Arm Intervention/treatment
Placebo Comparator: Control Drug: Control: Saline
Active Comparator: Interventional Drug: Tranexamic Acid



Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738073


Contacts
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Contact: Tiffany Morrison, MS, CCRP 267-339-7818 tiffany.morrison@rothmaninstitute.com

Locations
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United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02738073    
Other Study ID Numbers: 14RGOOD01
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants