The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery

NCT ID: NCT02164565

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.

Detailed Description

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Conditions

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Femur Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tranexamic Acid (TXA) treatment

Tranexamic Acid (TXA) treatment

Group Type EXPERIMENTAL

Tranexamic Acid (TXA) treatment

Intervention Type DRUG

Tranexamic Acid (TXA) treatment

control grup: without Tranexamic Acid (TXA) treatment.

control grup: without Tranexamic Acid (TXA) treatment.

Group Type EXPERIMENTAL

control grup: without Tranexamic Acid (TXA) treatment.

Intervention Type DRUG

control grup: without Tranexamic Acid (TXA) treatment.

Interventions

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Tranexamic Acid (TXA) treatment

Tranexamic Acid (TXA) treatment

Intervention Type DRUG

control grup: without Tranexamic Acid (TXA) treatment.

control grup: without Tranexamic Acid (TXA) treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
* Sound judgment

Exclusion Criteria

* Known hypersensitivity to Tranexamic Acid or component solution provided
* Subarachnoid hemorrhage
* Acquired color blindness
* Myocardial infarction in 12 months before admission
* Unstable angina
* Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability),
* Kidney or liver failure
* Another situation prostate resection , pathologic fractures according to anamnesis or by imaging
* Oncology patients
* Patients on anticoagulation
* Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nimrod Rozen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Division of Orthopedic & Rehabilitatio, HaEmek Medical Center

Locations

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Orthopedic Department, HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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104-12-EMC

Identifier Type: -

Identifier Source: org_study_id

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