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

Blood Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374398
• Other study ID #: 10-1-M-194
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2015
• Last updated: January 28, 2016
• Start date: March 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Eastern Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
see arm/group descriptions

Device:
• Aquamantys System
see arm/group descriptions

Other:
• Control Group
Saline and Standard Elecdrocautery

Locations

Country	Name	City	State
United States	Eastern Maine Medical Center	Bangor	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Maine Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

Allain JP, Stramer SL, Carneiro-Proietti AB, Martins ML, Lopes da Silva SN, Ribeiro M, Proietti FA, Reesink HW. Transfusion-transmitted infectious diseases. Biologicals. 2009 Apr;37(2):71-7. doi: 10.1016/j.biologicals.2009.01.002. Epub 2009 Feb 20. Review. — View Citation

Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. Epub 2007 Dec 7. — View Citation

Diamond PT, Conaway MR, Mody SH, Bhirangi K. Influence of hemoglobin levels on inpatient rehabilitation outcomes after total knee arthroplasty. J Arthroplasty. 2006 Aug;21(5):636-41. — View Citation

Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. — View Citation

Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. — View Citation

Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. — View Citation

Hynes M, Calder P, Scott G. The use of tranexamic acid to reduce blood loss during total knee arthroplasty. Knee. 2003 Dec;10(4):375-7. — View Citation

Isabell G and Weeden S. Hemodynamic efficacy of a bipolar sealing device in primary total knee arthroplasty(abstract). Annual Meeting of the Texas Orthopedic Association, Houston, TX; 2006.

Jansen AJ, Andreica S, Claeys M, D'Haese J, Camu F, Jochmans K. Use of tranexamic acid for an effective blood conservation strategy after total knee arthroplasty. Br J Anaesth. 1999 Oct;83(4):596-601. — View Citation

Lozano M, Basora M, Peidro L, Merino I, Segur JM, Pereira A, Salazar F, Cid J, Lozano L, Mazzara R, Macule F. Effectiveness and safety of tranexamic acid administration during total knee arthroplasty. Vox Sang. 2008 Jul;95(1):39-44. doi: 10.1111/j.1423-04 — View Citation

Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83. — View Citation

Sehat KR, Evans R, Newman JH. How much blood is really lost in total knee arthroplasty?. Correct blood loss management should take hidden loss into account. Knee. 2000 Jul 1;7(3):151-155. — View Citation

Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. — View Citation

Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2. Review. — View Citation

Veien M, Sørensen JV, Madsen F, Juelsgaard P. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand. 2002 Nov;46(10):1206-11. — View Citation

Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Post operative blood loss	Transfusion rates and total number of red blood cells (RBC) administered	day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups	No
Secondary	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	No
Secondary	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	Yes