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

Hip Fracture Clinical Trial

Official title:

The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures: A Prospective, Double-Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01940536
• Other study ID #: 13083
• Status: Withdrawn
• Phase: Phase 4
• First received: September 9, 2013
• Last updated: March 24, 2017
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Fractures, Bone
• Hemorrhage
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Tranexamic Acid
antifibrinolytic
• Placebo
Placebo

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood transfusion rate		Hospital stay (3-7 days)
Secondary	Calculated Blood Loss		Hospial Stay (3-7 days)
Secondary	Infection rate	Surgical site infection, Pneumonia, etc	30-day
Secondary	Reoperation Rate		1 year
Secondary	Hospital Length of Stay	Length o acue hospitalization for initial injury and surgery	30-day
Secondary	Myocardial Infarction		1 year
Secondary	Cost of acute care	Cost of initial hospital say and surgical intervention until initial discharge	30-day
Secondary	DVT o Cerebrovascular Event		1 year