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

NCT02427412 | Completed Phase 4 DMC

• 1 other identifier: H-3-2013-134
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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.

Outcome Measures

Primary Outcomes (1)

• Total estimated blood loss

  24 hours surgery

Secondary Outcomes (3)

• Total estimated blood loss

  2 days after surgery

• Thromboembolic complications

  90 days postoperative

• Blood transfusion

  while hospitalized expected 3 days.

Study Arms (2)

IA Tranexamic acid + IV Tranexamic Acid

ACTIVE COMPARATOR

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

IA Saline Water + IV tranexamic Acid

PLACEBO COMPARATOR

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; Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

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

Also known as: Cyclokapron

IA Tranexamic acid + IV Tranexamic Acid

Saline water DRUG

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

Also known as: NaCl water

IA Saline Water + IV tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Denmark

Location

MeSH Terms

Conditions

Hemorrhage; Postoperative Hemorrhage

Interventions

Tranexamic Acid; Saline Waters

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Environment; Ecological and Environmental Phenomena; Biological Phenomena

Study Officials

• Henrik Husted, PhD

  Hvidovre University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 28, 2015
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 17, 2015

Record last verified: 2015-05

Locations

DK (1)