Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty
NCT ID: NCT02427412
Last Updated: 2015-08-17
Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2014-01-31
2015-05-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Tranexamic Acid
An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.
Tranexamic Acid
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.
Saline water
30 ml of Saline water injected into the knee capsula at the end of surgery.
Tranexamic Acid
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.
Saline water
30 ml of Saline water injected into the knee capsula at the end of surgery.
Tranexamic Acid
An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unilateral knee replacement
* Must be able to give oral and written consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Christian Skovgaard Nielsen
MD
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
Countries
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Other Identifiers
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H-3-2013-134
Identifier Type: -
Identifier Source: org_study_id
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