Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty

NCT ID: NCT02427412

Last Updated: 2015-08-17

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.

Detailed Description

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Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.

In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.

Conditions

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Blood Loss Postoperative Blood Loss Thromboembolic Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IA Tranexamic acid + IV Tranexamic Acid

3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.

Tranexamic Acid

Intervention Type DRUG

An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.

IA Saline Water + IV tranexamic Acid

30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.

Group Type PLACEBO_COMPARATOR

Saline water

Intervention Type DRUG

30 ml of Saline water injected into the knee capsula at the end of surgery.

Tranexamic Acid

Intervention Type DRUG

An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.

Interventions

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Tranexamic Acid

An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.

Intervention Type DRUG

Saline water

30 ml of Saline water injected into the knee capsula at the end of surgery.

Intervention Type DRUG

Tranexamic Acid

An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.

Intervention Type DRUG

Other Intervention Names

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Cyclokapron NaCl water Cyklocapron

Eligibility Criteria

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Inclusion Criteria

* \> 18 years old
* Unilateral knee replacement
* Must be able to give oral and written consent

Exclusion Criteria

* General Anesthetized
* Allergic to Tranexamic acid
* In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
* Use of oral anticonceptive.
* Reduced kidney function (S-creatinine \> 120 micromol/L)
* Medicine or alcohol abuse
* Females with menstruation within the last 12 mounts.
* Any kind of cancer disease
* Rheumatoid arthritis
* Have participated in a clinical trial within the last 30 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christian Skovgaard Nielsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henrik Husted, PhD

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-3-2013-134

Identifier Type: -

Identifier Source: org_study_id

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