We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01940536
Recruitment Status : Withdrawn (Possible change in study protocol)
First Posted : September 12, 2013
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
The goal of this study is to determine if the use of tranexamic acid, a safe and effective antifibrinolytic, in patients with intertrochanteric hip fractures will result in a reduction in blood transfusion rates. Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, cost of inpatient care, and rate of adverse events, including DVT, PE, infection, MI, cerebrovascular event, need for re-hospitalization or re-operation and 30 day mortality.

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

Detailed Description:

All patients meeting specified criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient or health care proxy upon diagnosis of intertrochanteric hip fracture by the on-call orthopedic resident or research coordinator. At that time, each patient will be randomized into one of two cohorts (Figure 1) by the hospital's Investigational Pharmacy using computer generated randomization and allocation concealment. The Investigational Pharmacy will also be responsible for the storage, preparation and distribution of both the tranexamic acid and the placebo injections. The two patient groups will include:

  1. 1g of intra-venous tranexamic acid upon presentation to the emergency department and again at the time of surgical incision.
  2. Placebo injections upon presentation to the emergency department and again at the time of surgical incision.

Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study. All patients will be treated surgically with a long trochanteric femoral nail (TFN). Blood transfusion criteria will remain consistent with hospital standards (Hb<8 g/dL or symptomatic anemia) as determined by an independent, blinded medical team who will follow the patient throughout the hospital stay. Total number of blood transfusions received will be documented upon patient discharge.

All patients will be permitted to weight bear as tolerated post-operatively and deep vein thrombosis (DVT) prophylaxis will be standardized: subcutaneous heparin, 5000 units every 8 hours beginning upon admission until 12 hours prior to surgery and beginning 6 hours after surgery for a total of 6 weeks. Calf mechanical compression devices will also be utilized during the inpatient stay and will remain on at all times with the exception of physical therapy sessions. Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use. Patients will be followed at regular intervals (6wk, 3mo, 6mo, 1 year) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization) that have occurred since their last visit. In cases where patients are unable to accurately report their medical history, care providers will be questioned and records will be obtained from care facilities if necessary. An attempt will be made to contact any patient who is lost to follow-up via telephone and U.S. Mail.

Safety of the study will be monitored by an independent Data Safety Monitoring Board at 6 month intervals and the study will be discontinued at their discretion based on the number of adverse events.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures: A Prospective, Double-Blind, Randomized Controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Tranexamic Acid
1g tranexamic acid, intravenous, at time of sudy enrollment and again a surgical incision
Drug: Tranexamic Acid
Other Name: Cyclokapron

Placebo Comparator: Placebo Injection
Placebo injection (normal saline) a time of study enrollment and again at time of surgical incision
Drug: Placebo

Primary Outcome Measures :
  1. Blood transfusion rate [ Time Frame: Hospital stay (3-7 days) ]

Secondary Outcome Measures :
  1. Calculated Blood Loss [ Time Frame: Hospial Stay (3-7 days) ]
  2. Infection rate [ Time Frame: 30-day ]
    Surgical site infection, Pneumonia, etc

  3. Reoperation Rate [ Time Frame: 1 year ]
  4. Hospital Length of Stay [ Time Frame: 30-day ]
    Length o acue hospitalization for initial injury and surgery

  5. Myocardial Infarction [ Time Frame: 1 year ]
  6. Cost of acute care [ Time Frame: 30-day ]
    Cost of initial hospital say and surgical intervention until initial discharge

  7. DVT o Cerebrovascular Event [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Intertrochanteric Hip Fracture
  • Age >18

Exclusion Criteria:

  • Preoperative use of anticoagulant (Clopidogrel, Warfarin, Enoxaparin, Fondaparinux, Rivaroxaban
  • Allergy to Tranexamic Acid
  • History of intracranial hemorrhage or significant GI or retroperitoneal bleed requiring hospitalization
  • History of thromboembolic event (Stroke, Deep Vein Thrombosis, Pulmonary Embolism)
  • History of cirrhosis or evidence of hepatic (AST/ALT >60) or renal dysfunction (Cr >1.5 or GFR <30)
  • Coronary stents or prior diagnosis of CAD
  • Color blindness

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): NCT01940536

Layout table for location information
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Layout table for investigator information
Principal Investigator: Dean G Lorich, MD Hospital for Special Surgery, New York
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01940536    
Other Study ID Numbers: 13083
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Keywords provided by Hospital for Special Surgery, New York:
Hip Fracture
Blood Transfusion
Blood Loss
Tranexamic Acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action