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

Primary Purpose

Blood Loss, Postoperative Blood Loss, Thromboembolic Complications

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Tranexamic Acid
Saline water
Tranexamic Acid
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring 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.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IA Tranexamic acid + IV Tranexamic Acid

IA Saline Water + IV tranexamic Acid

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Total estimated blood loss

Secondary Outcome Measures

Total estimated blood loss
Thromboembolic complications
90 days followup for thromboembolic complications.
Blood transfusion
Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement

Full Information

First Posted
April 20, 2015
Last Updated
August 13, 2015
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02427412
Brief Title
Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty
Official Title
Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Postoperative Blood Loss, Thromboembolic Complications
Keywords
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IA Tranexamic acid + IV Tranexamic Acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IA Saline Water + IV tranexamic Acid
Arm Type
Placebo Comparator
Arm Description
30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyclokapron
Intervention Description
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
Intervention Name(s)
Saline water
Other Intervention Name(s)
NaCl water
Intervention Description
30 ml of Saline water injected into the knee capsula at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklocapron
Intervention Description
An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.
Primary Outcome Measure Information:
Title
Total estimated blood loss
Time Frame
24 hours surgery
Secondary Outcome Measure Information:
Title
Total estimated blood loss
Time Frame
2 days after surgery
Title
Thromboembolic complications
Description
90 days followup for thromboembolic complications.
Time Frame
90 days postoperative
Title
Blood transfusion
Description
Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement
Time Frame
while hospitalized expected 3 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Husted, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
Country
Denmark

12. IPD Sharing Statement

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

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