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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01940536
First received: September 9, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Hip Fracture
Blood Loss
Drug: Tranexamic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Blood transfusion rate [ Time Frame: Hospital stay (3-7 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Calculated Blood Loss [ Time Frame: Hospial Stay (3-7 days) ] [ Designated as safety issue: Yes ]
  • Infection rate [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Surgical site infection, Pneumonia, etc

  • Reoperation Rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Hospital Length of Stay [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Length o acue hospitalization for initial injury and surgery

  • Myocardial Infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cost of acute care [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    Cost of initial hospital say and surgical intervention until initial discharge

  • DVT o Cerebrovascular Event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: August 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tranexamic Acid
1g tranexamic acid, intravenous, at time of sudy enrollment and again a surgical incision
Drug: Tranexamic Acid
antifibrinolytic
Other Name: Cyclokapron
Placebo Comparator: Placebo Injection
Placebo injection (normal saline) a time of study enrollment and again at time of surgical incision

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940536

Contacts
Contact: Matthew R Garner, MD 212-606-1466 garnerm@hss.edu

Locations
United States, New York
New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Principal Investigator: Dean G Lorich, MD         
Sub-Investigator: Joseph M Lane, MD         
Sub-Investigator: Matthew R Garner, MD         
Sub-Investigator: Eric Brumberger, MD         
Sub-Investigator: Tiffany Tedore, MD         
Sub-Investigator: Eva Flores, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Dean G Lorich, MD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01940536     History of Changes
Other Study ID Numbers: 13083
Study First Received: September 9, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Hospital for Special Surgery, New York:
Hip Fracture
Blood Transfusion
Blood Loss
Tranexamic Acid

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

ClinicalTrials.gov processed this record on September 16, 2014