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

NCT ID: NCT01940536

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-12-31

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.

Conditions

Hip Fracture; Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid

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

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

antifibrinolytic

Placebo Injection

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Tranexamic Acid

antifibrinolytic

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Cyclokapron

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean G Lorich, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

New York Presbyterian Hospital

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27329438 (View on PubMed)

Other Identifiers

13083

Identifier Type: -

Identifier Source: org_study_id