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Completed

NCT Number: NCT02374398

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

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.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

see arm/group descriptions

Other names: Cyklokapron

Aquamantys System

Device

see arm/group descriptions

Control

Other

Standard Electro-cautery and Saline

Other names: Placebo

Primary outcomes

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

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

    • 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

  2. The Change in Hematocrit (Ht) From the Day of Surgery

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

    • 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

Secondary outcomes

  1. Post Operative Blood Loss

    Time frame: 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.

  2. Cost Analysis

    Time frame: 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.

  3. Adverse Events

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Eastern Maine Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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