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

NCT01940536 | Withdrawn Phase 4 DMC

• 1 other identifier: 13083
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fracture; Blood Loss

Keywords

Hip Fracture; Blood Transfusion; Blood Loss; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Blood transfusion rate

  Hospital stay (3-7 days)

Secondary Outcomes (7)

• Calculated Blood Loss

  Hospial Stay (3-7 days)

• Infection rate

  30-day

• Reoperation Rate

  1 year

• Hospital Length of Stay

  30-day

• Myocardial Infarction

  1 year

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

Placebo Injection

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tranexamic Acid DRUG

antifibrinolytic

Also known as: Cyclokapron

Tranexamic Acid

Placebo DRUG

Placebo

Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intertrochanteric Hip Fracture
• Age \>18

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 27329438 DERIVED

MeSH Terms

Conditions

Hip Fractures; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dean G Lorich, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (1)