Clinical trial NCT01940536: The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures
Official title: The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures: A Prospective, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hip Fracture
Blood Loss
Keywords: Hip Fracture
Blood Transfusion
Blood Loss
Tranexamic Acid
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2013-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Blood transfusion rate
timeFrame: Hospital stay (3-7 days)
Secondary outcomes:
measure: Calculated Blood Loss
timeFrame: Hospial Stay (3-7 days)
measure: Infection rate
timeFrame: 30-day
measure: Reoperation Rate
timeFrame: 1 year
measure: Hospital Length of Stay
timeFrame: 30-day
measure: Myocardial Infarction
timeFrame: 1 year
measure: Cost of acute care
timeFrame: 30-day
measure: DVT o Cerebrovascular Event
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Dean G Lorich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gausden EB, Garner MR, Warner SJ, Levack A, Nellestein AM, Tedore T, Flores E, Lorich DG. Tranexamic acid in hip fracture patients: a protocol for a randomised, placebo controlled trial on the efficacy of tranexamic acid in reducing blood loss in hip fracture patients. BMJ Open. 2016 Jun 21;6(6):e010676. doi: 10.1136/bmjopen-2015-010676.