Clinical trial NCT02374398: Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Keywords: Tranexamic Acid
Blood Loss
Aquamantys System
TKA
Lead sponsor: Eastern Maine Medical Center
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The Change in Hemoglobin (Hb) From the Day of Surgery
timeFrame: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
measure: The Change in Hematocrit (Ht) From the Day of Surgery
timeFrame: 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:
measure: Post Operative Blood Loss
timeFrame: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
measure: Cost Analysis
timeFrame: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
measure: Adverse Events
timeFrame: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
Other outcomes:
Locations:
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
Study officials:
affiliation: Eastern Maine Medical Center
name: Barbara Sorondo, MD
role: STUDY_DIRECTOR
References: