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Blood Loss After Early TXA in Hip Fractures.

NCT04488367 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-07-19

No results posted yet for this study

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.

Conditions

  • Hip Fractures

Interventions

DRUG

Tranexamic acid

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

DRUG

Normal Saline

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

Sponsors & Collaborators

  • Community Memorial Health System

    lead OTHER

Principal Investigators

  • Michael Allen, DO · Resident physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488367 on ClinicalTrials.gov