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

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ClinicalTrials.gov Identifier: NCT02427412
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Christian Skovgaard Nielsen, Hvidovre University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Loss Postoperative Blood Loss Thromboembolic Complications Drug: Tranexamic Acid Drug: Saline water Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Tranexamic Acid
An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.
Other Name: Cyclokapron

Drug: Tranexamic Acid
An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.
Other Name: Cyklocapron

Placebo Comparator: 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.
Drug: Saline water
30 ml of Saline water injected into the knee capsula at the end of surgery.
Other Name: NaCl water

Drug: Tranexamic Acid
An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.
Other Name: Cyklocapron




Primary Outcome Measures :
  1. Total estimated blood loss [ Time Frame: 24 hours surgery ]

Secondary Outcome Measures :
  1. Total estimated blood loss [ Time Frame: 2 days after surgery ]
  2. Thromboembolic complications [ Time Frame: 90 days postoperative ]
    90 days followup for thromboembolic complications.

  3. Blood transfusion [ Time Frame: while hospitalized expected 3 days. ]
    Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427412


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Study Director: Henrik Husted, PhD Hvidovre University Hospital
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Responsible Party: Christian Skovgaard Nielsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02427412    
Other Study ID Numbers: H-3-2013-134
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: May 2015
Keywords provided by Christian Skovgaard Nielsen, Hvidovre University Hospital:
Tranexamic Acid
Knee Arthroplasty
Blood loss
Blood transfusion
Thrombolic complication
Total blood loss 24 h after ended surgery.
Total blood loss 2 days after ended surgery.
Additional relevant MeSH terms:
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Hemorrhage
Postoperative Hemorrhage
Exsanguination
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants