The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures
|Study Design:||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|
- Blood transfusion rate [ Time Frame: Hospital stay (3-7 days) ]
- Calculated Blood Loss [ Time Frame: Hospial Stay (3-7 days) ]
- Infection rate [ Time Frame: 30-day ]Surgical site infection, Pneumonia, etc
- Reoperation Rate [ Time Frame: 1 year ]
- Hospital Length of Stay [ Time Frame: 30-day ]Length o acue hospitalization for initial injury and surgery
- Myocardial Infarction [ Time Frame: 1 year ]
- Cost of acute care [ Time Frame: 30-day ]Cost of initial hospital say and surgical intervention until initial discharge
- DVT o Cerebrovascular Event [ Time Frame: 1 year ]
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940536
|United States, New York|
|New York Presbyterian Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Dean G Lorich, MD||Hospital for Special Surgery, New York|