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

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01940536

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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:

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tranexamic Acid 1g tranexamic acid, intravenous, at time of sudy enrollment and again a surgical incision	Drug: Tranexamic Acid antifibrinolytic Other Names: Cyclokapron
Placebo Comparator: Placebo Injection Placebo injection (normal saline) a time of study enrollment and again at time of surgical incision	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: Tranexamic Acid

1g tranexamic acid, intravenous, at time of sudy enrollment and again a surgical incision

Drug: Tranexamic Acid

antifibrinolytic

Other Names:

Cyclokapron

Placebo Comparator: Placebo Injection

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

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Blood transfusion rate [Hospital stay (3-7 days)]

Secondary Outcome Measures

Calculated Blood Loss [Hospial Stay (3-7 days)]
Infection rate [30-day]
Surgical site infection, Pneumonia, etc
Reoperation Rate [1 year]
Hospital Length of Stay [30-day]
Length o acue hospitalization for initial injury and surgery
Myocardial Infarction [1 year]
Cost of acute care [30-day]
Cost of initial hospital say and surgical intervention until initial discharge
DVT o Cerebrovascular Event [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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