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Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures

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ClinicalTrials.gov Identifier: NCT02908516
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The primary objective of this study is to assess the safety and efficacy of Tranexamic acid (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip fractures. In addition to assessing blood loss in these patients, complications associated with TXA use would be characterized including systemic (pulmonary embolism, deep venous thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events, need for re-hospitalization or re-operation and 30 day mortality.

Condition or disease Intervention/treatment Phase
Hip Fractures Blood Loss Drug: Tranexamic Acid Drug: Placebo Phase 4

Detailed Description:

Hip fractures are associated with significant blood loss and a subsequent need for blood transfusion. The causes of bleeding are multifactorial, increased fibrinolytic activity being one of them. The use of allogenic blood products is expensive and is associated with increased risk of hemolytic and anaphylactic reactions, post-operative infections and lengthened hospital stay. Tranexamic acid (TXA) is a simple and inexpensive pharmacological agent that inhibits fibrinolysis and reduced bleeding. It has a 44 year history of clinical use beginning with patients with symptomatic menorrhagia as well as bleeding prophylaxis in hemophiliac patients undergoing tooth extraction

Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. It has been used successfully in orthopedics to reduce perioperative blood loss, particularly in spine surgery, total knee and total hip arthroplasty (THA). Multiple recent meta-analyses have found that use of TXA in the setting of total knee arthroplasty (TKA) and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications.

Osteoporotic hip fractures are at an increased risk than elective orthopaedic surgery patients because they are exposed to a double bleeding insult. Fractures bleed and many of these patients sustain their first hit when hematoma forms in their soft tissues leading to symptomatic anemia. Subsequently these patients sustain additional blood loss when they undergo surgery for definitive treatment of their injuries.

Trauma surgeons understand the risk of hemorrhage associated with trauma and routinely give TXA to patients who present with high energy injuries. The CRASH-2 trial was an international study which randomized 20,000 bleeding trauma patients to get TXA or matching placebo upon presentation. With 99.5% follow up, the authors noted a decreased risk of bleeding and death without ill effect.

However, there are limited data on its use in patients with hip fractures. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of femur fractures. Thus our goal is to examine the safety and efficacy of TXA in reducing blood loss and red blood cell requirement for patients with intertrochanteric, subtrochanteric femur fractures at the time of hospital admission.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Oral Tranexamic Acid in Reducing Blood Loss and Transfusion in Femoral Neck, Intertrochanteric and Subtrochanteric Femur Fractures 100 FR 1 (2015-2)
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid
Study subjects randomized to receive the TXA group will receive 3 oral capsules of 650 mg each of TXA for a total of 1.95 g. One dose will be given upon diagnosis of a hip fracture in the emergency department (ED) and a second dose will be given two hours prior to surgical incision.
Drug: Tranexamic Acid
2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.

Placebo Comparator: Placebo
Study subjects randomized to the placebo group will receive an equivalent dose of cellulose in 3 oral capsules. One dose will be given upon diagnosis of a hip fracture in the ED and a second dose will be given two hours prior to surgical incision.
Drug: Placebo
2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.




Primary Outcome Measures :
  1. Total Blood loss [ Time Frame: Postoperative day 3 ]
  2. Change in Hemoglobin level [ Time Frame: From presentation until postoperative day 3 ]
  3. Number of Transfusion events [ Time Frame: Postoperative day 3 ]

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: During hospitalization, likely less than 1 week ]
  2. Complications [ Time Frame: 6 weeks ]


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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 presenting with femoral neck, intertrochanteric and subtrochanteric femur fractures Patients age 18 and older Low energy injury

Exclusion Criteria:

Pregnant or breast-feeding women Allergy to tranexamic acid Acquired disturbances of color vision Thrombophilia Antithrombin deficiency Factor V Leiden Antiphospholipid Syndrome Protein C and S deficiency History of heparin induced thrombocytopenia Sickle cell anemia Myeloproliferative disorders International Normalized Ratio (INR) > 1.4 Partial Thromboplastin Time (PTT) > 1.4 times normal A history of arterial or venous thromboembolism Cerebral Vascular Accident Deep Vein Thrombosis Pulmonary Embolism Subarachnoid hemorrhage Active intravascular clotting Participation in another clinical trial


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): NCT02908516


Contacts
Contact: Adrian K Wyllie, MD 203-491-8100 adrian.wyllie@yale.edu
Contact: Stephen Nelson, MD 860-463-5933 stephen.nelson@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06515
Contact: Stephen K Nelson, MD    860-463-5933    stephen.nelson@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Michael P Leslie, DO Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02908516     History of Changes
Other Study ID Numbers: 2000020122
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Hemorrhage
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants