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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Christian Skovgaard Nielsen, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT02427412

First received: April 20, 2015

Last updated: August 13, 2015

Last verified: May 2015

History of Changes

Purpose

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	Intervention	Phase
Blood Loss Postoperative Blood Loss Thromboembolic Complications	Drug: Tranexamic Acid Drug: Saline water	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water Knee Replacement

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Further study details as provided by Christian Skovgaard Nielsen, Hvidovre University Hospital:

Primary Outcome Measures:

Total estimated blood loss [ Time Frame: 24 hours surgery ]

Secondary Outcome Measures:

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


Enrollment:	60
Study Start Date:	January 2014
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02427412

Locations


Denmark
Hvidovre University Hospital
Hvidovre, Denmark

Sponsors and Collaborators

Hvidovre University Hospital

Investigators


Study Director:	Henrik Husted, PhD	Hvidovre University Hospital

More Information


Responsible Party:	Christian Skovgaard Nielsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT02427412 History of Changes
Other Study ID Numbers:	H-3-2013-134
Study First Received:	April 20, 2015
Last Updated:	August 13, 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:


Exsanguination Hemorrhage Postoperative Hemorrhage Pathologic Processes Postoperative Complications Tranexamic Acid	Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants

ClinicalTrials.gov processed this record on July 13, 2017

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