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Blood Loss Reduction After Total Knee Arthroplasty. A Comparison Between Topical Tranexamic Acid and Platelet Rich Plasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02650856
Recruitment Status : Unknown
Verified January 2016 by FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon.
Recruitment status was:  Recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon

Brief Summary:
The investigators will include patients who will be schedule for total knee arthroplasty with a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a verbal and clear detailed information will be given on the intraoperative approach. The first group will receive topical tranexamic acid and the second group topical platelet rich plasma; both in the surgical site. Both groups will be assessed before and after the intervention with clinical scales (VAS) and laboratory results (hemoglobin, hematocrit levels) and transfusion rate.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Group 1 Tranexamic Acid Biological: Group 2 Platelet rich plasma Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Loss Reduction After Total Knee Arthroplasty. A Comparison Between Topical Tranexamic Acid and Platelet Rich Plasma: Controlled Clinical Trial
Study Start Date : September 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 Tranexamic acid

A dosis of 2 gr of tranexamic acid (1000mg/10mL X-GEN pharmaceuticals inc.) diluted in 80mL of physiologic solution and will be divided in two applications.

First application: 40mL of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.

Second application: The rest of 40mL of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.

Drug: Group 1 Tranexamic Acid
2 gr of tranexamic acid will be applied on the surgical site.

Active Comparator: Group 2 Platelet rich plasma

A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.

First application: 8 mL of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.

Second application: The rest of the 8 mL are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.

Biological: Group 2 Platelet rich plasma
16ml of platelet rich plasma will be applied of the surgical site




Primary Outcome Measures :
  1. Therapeutic effect on Hemoglobin level [ Time Frame: The third day postoperative ]
    The blood test will be taken at 6am every day. Using the same laboratory parameters.


Secondary Outcome Measures :
  1. Therapeutic effect on Hematocrit level [ Time Frame: Third day in the postoperative ]
    The blood test will be taken at 6am every day. Using the same laboratory parameters.

  2. Therapeutic effect on Drainage quantification [ Time Frame: Second day in the postoperative ]
    The blood quantification will be taken at 6am every day.

  3. Therapeutic effect on visual analog scale [ Time Frame: Third day in the postoperative ]
    The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (scale of 10). It will be assessed as a numeric scale from 0 to 10.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Patient candidates for primary total knee replacement
  3. Patients willing to participate in the study and sign de inform consent

Exclusion Criteria:

  1. Patients with previous history of thromboembolic event in the last 6 months
  2. Patients candidates for revision total knee replacement
  3. Patients candidates for tumoral total knee replacement
  4. Patients candidates for bilateral total knee replacement
  5. Patient with cognitive deficit
  6. Previous history of coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650856


Contacts
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Contact: Felix Vilchez, MD, PHD fvc78@hotmail.com
Contact: Gregorio Villarreal, MD 005218115557776 villarrealga@gmail.com

Locations
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Mexico
Facultad de Medicina UANL Recruiting
Monterrey, Nuevo Leon, Mexico, 1-4469
Contact: Felix Vilchez, MD, PHD       fvc78@hotmail.com   
Contact: Gregorio Villarreal, MD    005218115557776    villarrealga@gmail.com   
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Felix Vilchez, MD, PHD Hospital Universitario, Universidad Autonoma de Nuevo Leon

Publications:

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Responsible Party: FELIX VILCHEZ CAVAZOS, Dr. med. José Félix Vilchez Cavazos, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT02650856    
Other Study ID Numbers: OR15-007
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon:
Blood loss
Tranexamic acid
Platelet rich plasma
Total knee arthroplasty
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants