Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture

NCT ID: NCT03251469

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-02-28

Brief Summary

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The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).

Detailed Description

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Conditions

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Blood Loss, Surgical Hip Fractures Complication, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

intravenous tranexamic acid, 15mg/kg, preoperatively, single dose

Group Type ACTIVE_COMPARATOR

Tranexamic Acid 15mg/kg , iv, Single Dose

Intervention Type DRUG

Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose

Group 2

Intravenous normal saline, 100mg, preoperatively, single dose

Group Type PLACEBO_COMPARATOR

Normal Saline, 100mg, iv, Singe dose

Intervention Type DRUG

Normal Saline, 100mg, administered intravenously, preoperatively in single dose

Interventions

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Tranexamic Acid 15mg/kg , iv, Single Dose

Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose

Intervention Type DRUG

Normal Saline, 100mg, iv, Singe dose

Normal Saline, 100mg, administered intravenously, preoperatively in single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Consecutive elderly patients (age \>75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture.

Exclusion Criteria

* Any contraindication for tranexamic acid
* Multiple fractures
* Requirement for anticoagulant therapy that could not be stopped.
* Ongoing thromboembolic event
* reduced kidney function
* malignancy,
* pathological fracture
* previous operation on the affected hip
* Active coronary artery disease (event in the past 12 months).
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Vasileios S. Nikolaou

Assistant Professor of Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Department of Orthopaedics

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Vasileios S Nikolaou, MD

Role: CONTACT

+306932543400

Facility Contacts

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Vasileios Nikolaou, MD

Role: primary

+306932543400

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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