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

Eastern Maine Medical Center

Status and phase: Completed; Phase 4

Conditions: Blood Loss

Treatments: Other: Control; Drug: Tranexamic Acid; Device: Aquamantys System

Study type: Interventional

Funder types: Other

Identifiers

NCT02374398

10-1-M-194

Details and patient eligibility

About

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.

Full 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

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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127 participants in 4 patient groups, including a placebo group

Tranexamic Acid

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid

Aquamantys System

Active Comparator group

Description:

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

Treatment:

Device: Aquamantys System

TXA plus Aquamantys

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Device: Aquamantys System

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Control