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Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty

NCT ID: NCT01260818

Last Updated: 2011-12-01

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Brief Summary

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Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty

Detailed Description

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Conditions

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Hip Replacement Postoperative Hemorrhage

Keywords

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Tranexamic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tranexamic Acid

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively

control group

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

100ml saline is kept in wound for 2 hours before drainage is opened postoperatively

Interventions

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Tranexamic Acid

1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively

Intervention Type DRUG

normal saline

100ml saline is kept in wound for 2 hours before drainage is opened postoperatively

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient who are to undergo elective total hip arthroplasty.
* Must be primary arthroplasty.
* Must be single-side arthroplasty.
* Must be older than 18 years.

Exclusion Criteria

* Cemented arthroplasty.
* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .
* Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
* Patients who have a past medical history of thrombi-embolism at any time.
* Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%).
* Patients with documented DVT or PE at screening or in past three months.
* Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product.
* Patients with any associated major illness (e.g., severe cardiac \[New York Heart Association Class III or IV\] or respiratory disease).
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.
* Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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the First Affiliated Hospital of Guangzhou TCM University

Principal Investigators

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Yong Li

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Locations

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the First Affiliated Hospital of Guangzhou TCM University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yong Li

Role: primary

Other Identifiers

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GZTCM-201001

Identifier Type: -

Identifier Source: org_study_id