Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)

NCT ID: NCT02374398

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-11-30

Brief Summary

The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.

Detailed Description

The study is randomized, placebo controlled. The study population includes patients older than 18 years of age undergoing elective total primary knee replacement under spinal anesthesia. All patients enrolled in the study will undergo TKA performed by the same orthopedic surgeon. Since controversies exist regarding the effect of different types of anesthesia (general anesthesia versus spinal or epidural anesthesia) on intraoperative blood loss, in order to eliminate an important confounding variable we decided to exclusively enroll for our study patients that qualify for and agree with spinal anesthesia to be used as the main anesthetic technique for their TKA.

All clinical trial procedures will be performed by personnel blinded to study treatment assignment. Unblinding is only allowed for safety concerns in an emergency situation.The only other exception is represented by the surgeon, who can't be blinded in regards to using Aquamantys system and the bipolar sealer. Once a subject becomes eligible for the trial, the investigator or the designee will access the randomization system.

Enrolled subjects will be assigned to one of the 4 groups by block randomization of alternating 4 and 8 and 12 patients per block. The Pharmacy Department will provide the iv placebo or the iv TXA according to the randomization process.

This clinical trial will be conducted in accordance to this protocol, Good Clinical Practice and applicable regulatory requirements

Conditions

Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic Acid

TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

see arm/group descriptions

Aquamantys System

The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts

Group Type: ACTIVE_COMPARATOR

Aquamantys System

Intervention Type: DEVICE

see arm/group descriptions

TXA plus Aquamantys

TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.

The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

see arm/group descriptions

Aquamantys System

Intervention Type: DEVICE

see arm/group descriptions

Control

Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Standard Electro-cautery and Saline

Interventions

Tranexamic Acid

see arm/group descriptions

Intervention Type: DRUG

Aquamantys System

see arm/group descriptions

Intervention Type: DEVICE

Control

Standard Electro-cautery and Saline

Intervention Type: OTHER

Other Intervention Names

Cyklokapron; Placebo

Eligibility Criteria

Inclusion Criteria

• Adult patients over age of 18 undergoing elective total primary knee arthroplasty under spinal anesthesia.

Exclusion Criteria

• Previous adverse reaction to tranexamic acid
• Congenital or acquired coagulation disorders
• Preoperative platelet count of less than 100,000/microliter or INR> 1.4
• History of deep venous thrombosis, pulmonary embolism or cerebrovascular accident
• Patients with acquired defective color vision
• Renal insufficiency (Glomerular filtration rate <20 ml/min)
• Severe liver disease
• Coronary stents
• Pregnant patients
• Main anesthetic other than spinal anesthesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Maine Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alexandru Seviciu, MD

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Sorondo, MD

Role: STUDY_DIRECTOR

Eastern Maine Medical Center

Locations

Eastern Maine Medical Center

Bangor, Maine, United States

Countries

United States

Other Identifiers

10-1-M-194

Identifier Type: -

Identifier Source: org_study_id