NCT04488367

Brief Summary

Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 16, 2020

Last Update Submit

July 18, 2022

Conditions

Hip Fractures

Keywords

tranexamic acidTXAhip fracture

Outcome Measures

Primary Outcomes (2)

  • Change in calculated and recorded hemoglobin

    Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.

    From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.

  • Total postoperative units of red blood cell transfusion

    The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.

    From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.

Secondary Outcomes (4)

  • VTE

    Postoperative for 30 days

  • Infection

    Postoperative for 30 days

  • Readmission

    Within 30 days postoperative

  • Other complications

    Postoperative for 30 days

Study Arms (2)

Early TXA

EXPERIMENTAL

Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.

Drug: Tranexamic acid

Control

OTHER

Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.

Drug: Normal Saline

Interventions

Tranexamic acidDRUG

10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU

Also known as: Early TXA
Early TXA
Normal SalineDRUG

100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU

Also known as: Control Placebo
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Femoral neck, intertrochanteric, subtrochanteric femur fracture
  • Age \>18
  • Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon

You may not qualify if:

  • Age \<18
  • Concomitant fracture
  • Preoperative anemia needing blood transfusion before surgery
  • Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
  • Allergy for tranexamic acid
  • History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
  • Myocardial infarction in the previous 12 months
  • Renal function impairment (creatinine clearance \<30 mL/min), or kidney transplant
  • History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Memorial Hospital

Ventura, California, 93003, United States

RECRUITING

Related Publications (7)

  • Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.

    PMID: 18349013BACKGROUND

  • Praetorius K, Madsen CM, Abrahamsen B, Jorgensen HL, Lauritzen JB, Laulund AS. Low Levels of Hemoglobin at Admission Are Associated With Increased 30-Day Mortality in Patients With Hip Fracture. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):115-20. doi: 10.1177/2151458516647989. Epub 2016 May 17.

    PMID: 27551568BACKGROUND

  • CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

    PMID: 20554319BACKGROUND

  • Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9.

    PMID: 28810918BACKGROUND

  • Baruah RK, Borah PJ, Haque R. Use of tranexamic acid in dynamic hip screw plate fixation for trochanteric fractures. J Orthop Surg (Hong Kong). 2016 Dec;24(3):379-382. doi: 10.1177/1602400322.

    PMID: 28031511BACKGROUND

  • Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.

    PMID: 28983887BACKGROUND

  • Tian S, Shen Z, Liu Y, Zhang Y, Peng A. The effect of tranexamic acid on hidden bleeding in older intertrochanteric fracture patients treated with PFNA. Injury. 2018 Mar;49(3):680-684. doi: 10.1016/j.injury.2018.01.026. Epub 2018 Feb 2.

    PMID: 29426608BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Michael Allen, DO

    Resident physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Allen, DO

CONTACT

805-948-5100mallen@cmhshealth.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 28, 2020

Study Start

July 6, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)