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

A Randomized, Controlled Clinical Trial Comparing the Use of Intravenous Tranexamic Acid With Aquamantys Bipolar Sealer for Blood Loss Reduction in Primary Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Drug: Tranexamic Acid; Device: Aquamantys System; Other: Control

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

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: Tranexamic Acid; see arm/group descriptions; Other Names: Cyklokapron
ACTIVE_COMPARATOR: 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	Device: Aquamantys System; see arm/group descriptions
ACTIVE_COMPARATOR: 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.	Drug: Tranexamic Acid; see arm/group descriptions; Other Names: Cyklokapron; Device: Aquamantys System; see arm/group descriptions
PLACEBO_COMPARATOR: 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	Other: Control; Standard Electro-cautery and Saline; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change in Hemoglobin (Hb) From the Day of Surgery	Control group- iv placebo normal saline plus regular electrocautery.; iv TXA plus regular electrocautery.; iv placebo plus Aquamantys system and regular electrocautery.; iv TXA and Aquamantys system and regular electrocautery	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
The Change in Hematocrit (Ht) From the Day of Surgery	Control group- iv placebo normal saline plus regular electrocautery.; iv TXA plus regular electrocautery.; iv placebo plus Aquamantys system and regular electrocautery.; iv TXA and Aquamantys system and regular electrocautery	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Blood Loss	The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross's formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below: Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial - Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two.	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
Cost Analysis	Charges per case.	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
Adverse Events	Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups

Collaborators and Investigators

• Sponsor: Eastern Maine Medical Center
• Investigators: Study Director: Barbara Sorondo, MD, Eastern Maine Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (ESTIMATE): February 27, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2017
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Blood Loss; Tranexamic Acid; TKA; Aquamantys System
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 10-1-M-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED