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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02374398

Enrollment

127

Registered

2015-02-27

Start date

2011-03-31

Completion date

2014-11-30

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss

Keywords

Tranexamic Acid, Blood Loss, Aquamantys System, TKA

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

Interventions

DRUGTranexamic Acid

see arm/group descriptions

DEVICEAquamantys System

see arm/group descriptions

OTHERControl

Standard Electro-cautery and Saline

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The Change in Hemoglobin (Hb) From the Day of Surgery	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups	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
The Change in Hematocrit (Ht) From the Day of Surgery	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups	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

Secondary

Measure	Time frame	Description
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	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.
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	Charges per case.
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	Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 Tranexamic Acid: see arm/group descriptions	29
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 Aquamantys System: see arm/group descriptions	31
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. Tranexamic Acid: see arm/group descriptions Aquamantys System: see arm/group descriptions	29
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 Control Group: Saline and Standard Elecdrocautery	32
Total	121

Baseline characteristics

Characteristic	Tranexamic Acid	Aquamantys System	TXA Plus Aquamantys	Control	Total
Age, Continuous	65.7 years STANDARD_DEVIATION 8.6	64.8 years STANDARD_DEVIATION 8	61.1 years STANDARD_DEVIATION 10.5	62.9 years STANDARD_DEVIATION 8.4	63.6 years STANDARD_DEVIATION 8.9
Gender Female	15 Participants	17 Participants	16 Participants	18 Participants	66 Participants
Gender Male	14 Participants	14 Participants	13 Participants	14 Participants	55 Participants
Region of Enrollment United States	29 participants	31 participants	29 participants	32 participants	121 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 31	0 / 32	0 / 32	0 / 32
serious Total, serious adverse events	0 / 31	0 / 32	0 / 32	0 / 32

Outcome results

Primary

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