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

NCT02374398 | Completed Phase 4 Results

• 1 other identifier: 10-1-M-194
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss

Keywords

Tranexamic Acid; Blood Loss; Aquamantys System; TKA

Outcome Measures

Primary Outcomes (2)

• The Change in Hemoglobin (Hb) From the Day of Surgery

  1. Control group- iv placebo normal saline plus regular electrocautery. 2. iv TXA plus regular electrocautery. 3. iv placebo plus Aquamantys system and regular electrocautery. 4. 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

  1. Control group- iv placebo normal saline plus regular electrocautery. 2. iv TXA plus regular electrocautery. 3. iv placebo plus Aquamantys system and regular electrocautery. 4. 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 Outcomes (3)

• Post Operative Blood Loss

  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

  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

  day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups

Study Arms (4)

Tranexamic Acid

ACTIVE COMPARATOR

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

Aquamantys System

ACTIVE COMPARATOR

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

TXA plus Aquamantys

ACTIVE COMPARATOR

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; Device: Aquamantys System

Control

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid DRUG

see arm/group descriptions

Also known as: Cyklokapron

TXA plus Aquamantys; Tranexamic Acid

Aquamantys System DEVICE

see arm/group descriptions

Aquamantys System; TXA plus Aquamantys

Control OTHER

Standard Electro-cautery and Saline

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Maine Medical Center: lead

Study Sites (1)

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Alexandru Seviciu
• Organization: Eastern Maine Medical Center

aseviciu@emhs.org

207-973-5918

Study Officials

• Barbara Sorondo, MD

  Eastern Maine Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 27, 2015
• Study Start: March 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

US (1)