OsteoarthritisPhase 3NCT02650856
Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma
A Phase 3 study testing Group 1 Tranexamic Acid and Group 2 Platelet rich plasma in people with Osteoarthritis, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Group 1 Tranexamic Acid and Group 2 Platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2015to 9 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patient candidates for primary total knee replacement
- Patients willing to participate in the study and sign de inform consent
Who cannot join
- Patients with previous history of thromboembolic event in the last 6 months
- Patients candidates for revision total knee replacement
- Patients candidates for tumoral total knee replacement
- Patients candidates for bilateral total knee replacement
- Patient with cognitive deficit
- Previous history of coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Loss Reduction After Total Knee Arthroplasty. A Comparison Between Topical Tranexamic Acid and Platelet Rich Plasma: Controlled Clinical Trial
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 laboratory results (hemoglobin, hematocrit levels) and drainage drain.
Read the detailed description
Total knee replacement (TKR) surgery is one the most common orthopedic procedure in the world. Morbidity in perioperative TKR is associated with: blood loss, pain, infection, wound complications, stiffness, and thrombotic events. Blood loss and transfusion have been associated with an increased hospital stay, costs, morbidity, and mortality. Indications for blood transfusions are now limited and it is well known that is not a free risk procedure. Complications such as; ABO incompatibility, viral transmission, hemolysis, immunosuppression, and wound infection have been reported.
Literature reports have reported blood loss in TKR ranging from 300ml to 1 liter, and transfusion rate varying from 10-38%. In diminishing hospital cost Moskal J. et al. reported 53.90% of savings and a 100% reduction in working hours of the hospital staff using topical tranexamic acid in TKR. Tranexamic acid is an antifibrinolytic agent that acts inhibiting the plasminogen, stabilizing the blood clot; it is used to stop surgical or traumatic bleeding like in the CRASH-2 trial, demonstrating its efficiency in polytraumatized patients. Tranexamic acid has been used in the last years for blood loss with good results. Due to its systemic effects and past medical history of myocardial infarction, stents, and previous thromboembolic events its intravenous use is limited. In this study, the investigators used topical tranexamic acid and its use has been proven in clinical trials as a secure strategy for blood loss reduction in TKR, without excluding patients with previous thromboembolic events.
Platelet-rich plasma (PRP) is an orthobiologic that has played an important role over the past decade in different areas like; spinal fusion, anterior cruciate ligament reconstruction, osteoarthritis, and tendinopathies. The use of PRP in orthopedics is overrated and true indications for its use and cost-benefit are still unclear. Retrospective studies like Pace T et al in 268 patients did not demonstrate differences in-hospital stay, Postoperative hemoglobin levels, and range of motion using PRP in TKR. Morishita M. et al. in a clinical trial of 40 patients, using intralesional PRP didn´t show any benefits for blood loss reduction in TKR, but good clinical results were observed in clinical scores like Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) compared to the control group. Other studies have demonstrated the efficacy of topical PRP in blood loss reduction in TKR.
Due to its high platelet concentration and growth factors contained in the alfa granules; it is used as a hemostatic, analgesic, and antiseptic agent in TKR.
There is a variety of blood loss prevention strategies for TKR and these strategies can be divided into preoperative, intraoperative, or postoperative. This study aimed to compare the use of topical tranexamic acid versus topical platelet-rich plasma.
An Insall knee approach, parapatellar medial will be used in all the patients. After the final cuts of the femoral, tibial and patellar and before placing the final cemented components the experimental intervention of the study will begin.
Group 1. A dose of 2 gr of tranexamic acid (1000mg/10 mL X-GEN pharmaceuticals inc.) is diluted in 80 mL of physiologic solution and will be divided into two applications:
First application: 40 mL 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 the 40 mL of solution previously prepared is applied after placing the final TKR cemented components (femoral, tibial, and patellar), over the surgical site and leaving it there without draining it by suction.
Group 2. In the preoperative room with previous premedication, a total of 55 mL of total venous blood is obtained from the forearm (cubital o basilic veins). The blood is carried on 12 sterile tubes using sodium citrate at 3.8% (BD, Vacutainer; Becton, Dickinson and Company, NJ). Blood samples are then transported to the Bone and Tissue Bank for centrifugation (1800 rpm for 10 minutes) to separate blood into the 3 layers (White, yellow and red). The superior layer rich in plasma will be collected in 50 microliters polypropylene tubes (Corning, NY). A final volume of 16 ml of platelet-rich plasma is obtained and transferred to airtight tubes (BD Vacutainer; Becton, Dickinson and Company, NJ). The manipulation of the blood samples is made on laminar flow cabin biosecurity class II (Logic 3440801; Labconco, KC). The platelet-rich plasma will be activated with calcium gluconate at 10% (Pisa Farmacéutica, Jalisco, México) before using it is placed in the surgical site topically. The PRP simple will be divided into two applications, initiating the intervention after the final cuts of the TKR components (like the tranexamic acid group).
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 over the surgical site after placing the final TKR cemented components (femoral, tibial, and patellar), over the surgical site and leaving it without draining.
Then a primary closure of the wound is performed (capsule, fascia, subcutaneous tissue, and skin) in both groups. Close drainage (Drenovac, NEdren S de R.L. de C.V.) is left intraarticular and fixed to the skin. The drainage will be clamped for 2 hours and removed at the 48 hours of the surgery. Thromboprophylaxis (low weight heparin) will be initiated after 6 hours of the end of the surgery. In the postoperative follow-up, any patient with hemoglobin levels less than 9mg/dL with the anemic syndrome will be transfused.
- Conditions
- Osteoarthritis
- Being tested
- Group 1 Tranexamic Acid, Group 2 Platelet rich plasma
- Keywords
- Blood loss, Tranexamic acid, Platelet rich plasma, Total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Tranexamic AcidDrug
Also called Topic Tranexamic Acid
2 gr of tranexamic acid will be applied on the surgical site.
Group 2 Platelet rich plasmaBiological
Also called PRP
16ml of platelet rich plasma will be applied of the surgical site
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Tranexamic acid | Experimental | 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. Receives: Drug: Group 1 Tranexamic Acid |
| Group 2 Platelet rich plasma | Active comparator | 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. Receives: Biological: Group 2 Platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Effect on Hemoglobin Level
The blood test will be taken at 6am every day. Using the same laboratory parameters.
Measured: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)
Secondary outcomes (2)
Therapeutic Effect on Hematocrit Level
The blood test will be taken at 6am every day. Using the same laboratory parameters.
Measured: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)
Therapeutic Effect on Drainage Quantification
The blood quantification will be taken at 6am every day.
Measured: up to 2nd day post operative (24 and 48 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startSep 2015
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon
- Investigators
- Felix Vilchez, MD, PHD, Principal investigator, Hospital Universitario, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650856
- Sponsor's protocol ID
- OR15-007
- Status last verified
- May 2021
- First submitted
- 29 Dec 2015
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Levine BR, Haughom B, Strong B, Hellman M, Frank RM. Blood management strategies for total knee arthroplasty. J Am Acad Orthop Surg. 2014 Jun;22(6):361-71. doi: 10.5435/JAAOS-22-06-361.
PubMed 24860132Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.
PubMed 23541868Frisch NB, Wessell NM, Charters MA, Yu S, Jeffries JJ, Silverton CD. Predictors and complications of blood transfusion in total hip and knee arthroplasty. J Arthroplasty. 2014 Sep;29(9 Suppl):189-92. doi: 10.1016/j.arth.2014.03.048. Epub 2014 May 24.
PubMed 25007727Moskal JT, Harris RN, Capps SG. Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012. J Arthroplasty. 2015 Mar;30(3):365-8. doi: 10.1016/j.arth.2014.10.008. Epub 2014 Oct 12.
PubMed 25458093CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154.
PubMed 22241606Patel JN, Spanyer JM, Smith LS, Huang J, Yakkanti MR, Malkani AL. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study. J Arthroplasty. 2014 Aug;29(8):1528-31. doi: 10.1016/j.arth.2014.03.011. Epub 2014 Mar 21.
PubMed 24768543Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):74-7. doi: 10.1016/j.arth.2013.06.037.
PubMed 24034510Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.
PubMed 23906869Sarzaeem MM, Razi M, Kazemian G, Moghaddam ME, Rasi AM, Karimi M. Comparing efficacy of three methods of tranexamic acid administration in reducing hemoglobin drop following total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1521-4. doi: 10.1016/j.arth.2014.02.031. Epub 2014 Mar 6.
PubMed 24726174Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.
PubMed 24196467Pace TB, Foret JL, Palmer MJ, Tanner SL, Snider RG. Intraoperative platelet rich plasma usage in total knee arthroplasty: does it help? ISRN Orthop. 2013 Jul 28;2013:740173. doi: 10.1155/2013/740173. eCollection 2013.
PubMed 24971180Morishita M, Ishida K, Matsumoto T, Kuroda R, Kurosaka M, Tsumura N. Intraoperative platelet-rich plasma does not improve outcomes of total knee arthroplasty. J Arthroplasty. 2014 Dec;29(12):2337-41. doi: 10.1016/j.arth.2014.04.007. Epub 2014 Apr 13.
PubMed 24851794Aggarwal AK, Shashikanth VS, Marwaha N. Platelet-rich plasma prevents blood loss and pain and enhances early functional outcome after total knee arthroplasty: a prospective randomised controlled study. Int Orthop. 2014 Feb;38(2):387-95. doi: 10.1007/s00264-013-2136-6. Epub 2013 Oct 11.
PubMed 24114251Bloomfield MR, Klika AK, Molloy RM, Froimson MI, Krebs VE, Barsoum WK. Prospective randomized evaluation of a collagen/thrombin and autologous platelet hemostatic agent during total knee arthroplasty. J Arthroplasty. 2012 May;27(5):695-702. doi: 10.1016/j.arth.2011.09.014. Epub 2011 Oct 27.
PubMed 22035976
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss Reduction After Total Knee Arthroplasty. A Comparison Between Topical Tranexamic Acid and Platelet Rich Plasma: Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02650856
- Acronym / sponsor ID
- OR15-007
- Conditions
- Osteoarthritis
- Keywords
- Blood loss, Tranexamic acid, Platelet rich plasma, Total knee arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 laboratory results (hemoglobin, hematocrit levels) and drainage drain.
Detailed description
Total knee replacement (TKR) surgery is one the most common orthopedic procedure in the world. Morbidity in perioperative TKR is associated with: blood loss, pain, infection, wound complications, stiffness, and thrombotic events. Blood loss and transfusion have been associated with an increased hospital stay, costs, morbidity, and mortality. Indications for blood transfusions are now limited and it is well known that is not a free risk procedure. Complications such as; ABO incompatibility, viral transmission, hemolysis, immunosuppression, and wound infection have been reported.
Literature reports have reported blood loss in TKR ranging from 300ml to 1 liter, and transfusion rate varying from 10-38%. In diminishing hospital cost Moskal J. et al. reported 53.90% of savings and a 100% reduction in working hours of the hospital staff using topical tranexamic acid in TKR. Tranexamic acid is an antifibrinolytic agent that acts inhibiting the plasminogen, stabilizing the blood clot; it is used to stop surgical or traumatic bleeding like in the CRASH-2 trial, demonstrating its efficiency in polytraumatized patients. Tranexamic acid has been used in the last years for blood loss with good results. Due to its systemic effects and past medical history of myocardial infarction, stents, and previous thromboembolic events its intravenous use is limited. In this study, the investigators used topical tranexamic acid and its use has been proven in clinical trials as a secure strategy for blood loss reduction in TKR, without excluding patients with previous thromboembolic events.
Platelet-rich plasma (PRP) is an orthobiologic that has played an important role over the past decade in different areas like; spinal fusion, anterior cruciate ligament reconstruction, osteoarthritis, and tendinopathies. The use of PRP in orthopedics is overrated and true indications for its use and cost-benefit are still unclear. Retrospective studies like Pace T et al in 268 patients did not demonstrate differences in-hospital stay, Postoperative hemoglobin levels, and range of motion using PRP in TKR. Morishita M. et al. in a clinical trial of 40 patients, using intralesional PRP didn´t show any benefits for blood loss reduction in TKR, but good clinical results were observed in clinical scores like Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) compared to the control group. Other studies have demonstrated the efficacy of topical PRP in blood loss reduction in TKR.
Due to its high platelet concentration and growth factors contained in the alfa granules; it is used as a hemostatic, analgesic, and antiseptic agent in TKR.
There is a variety of blood loss prevention strategies for TKR and these strategies can be divided into preoperative, intraoperative, or postoperative. This study aimed to compare the use of topical tranexamic acid versus topical platelet-rich plasma.
An Insall knee approach, parapatellar medial will be used in all the patients. After the final cuts of the femoral, tibial and patellar and before placing the final cemented components the experimental intervention of the study will begin.
Group 1. A dose of 2 gr of tranexamic acid (1000mg/10 mL X-GEN pharmaceuticals inc.) is diluted in 80 mL of physiologic solution and will be divided into two applications:
First application: 40 mL 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 the 40 mL of solution previously prepared is applied after placing the final TKR cemented components (femoral, tibial, and patellar), over the surgical site and leaving it there without draining it by suction.
Group 2. In the preoperative room with previous premedication, a total of 55 mL of total venous blood is obtained from the forearm (cubital o basilic veins). The blood is carried on 12 sterile tubes using sodium citrate at 3.8% (BD, Vacutainer; Becton, Dickinson and Company, NJ). Blood samples are then transported to the Bone and Tissue Bank for centrifugation (1800 rpm for 10 minutes) to separate blood into the 3 layers (White, yellow and red). The superior layer rich in plasma will be collected in 50 microliters polypropylene tubes (Corning, NY). A final volume of 16 ml of platelet-rich plasma is obtained and transferred to airtight tubes (BD Vacutainer; Becton, Dickinson and Company, NJ). The manipulation of the blood samples is made on laminar flow cabin biosecurity class II (Logic 3440801; Labconco, KC). The platelet-rich plasma will be activated with calcium gluconate at 10% (Pisa Farmacéutica, Jalisco, México) before using it is placed in the surgical site topically. The PRP simple will be divided into two applications, initiating the intervention after the final cuts of the TKR components (like the tranexamic acid group).
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 over the surgical site after placing the final TKR cemented components (femoral, tibial, and patellar), over the surgical site and leaving it without draining.
Then a primary closure of the wound is performed (capsule, fascia, subcutaneous tissue, and skin) in both groups. Close drainage (Drenovac, NEdren S de R.L. de C.V.) is left intraarticular and fixed to the skin. The drainage will be clamped for 2 hours and removed at the 48 hours of the surgery. Thromboprophylaxis (low weight heparin) will be initiated after 6 hours of the end of the surgery. In the postoperative follow-up, any patient with hemoglobin levels less than 9mg/dL with the anemic syndrome will be transfused.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Tranexamic acid | Experimental | Drug: Group 1 Tranexamic AcidA 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. |
| Group 2 Platelet rich plasma | Active comparator | Biological: Group 2 Platelet rich plasmaA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Patient candidates for primary total knee replacement
- Patients willing to participate in the study and sign de inform consent
Key exclusion criteria (6 listed)
- Patients with previous history of thromboembolic event in the last 6 months
- Patients candidates for revision total knee replacement
- Patients candidates for tumoral total knee replacement
- Patients candidates for bilateral total knee replacement
- Patient with cognitive deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 Tranexamic AcidAlso: Topic Tranexamic Acid2 gr of tranexamic acid will be applied on the surgical site. | Drug | Group 1 Tranexamic acid |
| Group 2 Platelet rich plasmaAlso: PRP16ml of platelet rich plasma will be applied of the surgical site | Biological | Group 2 Platelet rich plasma |
Primary outcome
Therapeutic Effect on Hemoglobin Level
Time frame: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)
The blood test will be taken at 6am every day. Using the same laboratory parameters.
2 secondary outcomes
Therapeutic Effect on Hematocrit Level
Time frame: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)
Therapeutic Effect on Drainage Quantification
Time frame: up to 2nd day post operative (24 and 48 hrs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24860132Levine BR, Haughom B, Strong B, Hellman M, Frank RM. Blood management strategies for total knee arthroplasty. J Am Acad Orthop Surg. 2014 Jun;22(6):361-71. doi: 10.5435/JAAOS-22-06-361.
- Background: PubMed 23541868Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.
- Background: PubMed 25007727Frisch NB, Wessell NM, Charters MA, Yu S, Jeffries JJ, Silverton CD. Predictors and complications of blood transfusion in total hip and knee arthroplasty. J Arthroplasty. 2014 Sep;29(9 Suppl):189-92. doi: 10.1016/j.arth.2014.03.048. Epub 2014 May 24.
- Background: PubMed 25458093Moskal JT, Harris RN, Capps SG. Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012. J Arthroplasty. 2015 Mar;30(3):365-8. doi: 10.1016/j.arth.2014.10.008. Epub 2014 Oct 12.
- Background: PubMed 20554319CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Background: PubMed 22241606Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154.
- Background: PubMed 24768543Patel JN, Spanyer JM, Smith LS, Huang J, Yakkanti MR, Malkani AL. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study. J Arthroplasty. 2014 Aug;29(8):1528-31. doi: 10.1016/j.arth.2014.03.011. Epub 2014 Mar 21.
- Background: PubMed 24034510Chimento GF, Huff T, Ochsner JL Jr, Meyer M, Brandner L, Babin S. An evaluation of the use of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):74-7. doi: 10.1016/j.arth.2013.06.037.
- Background: PubMed 23906869Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.
- Background: PubMed 24726174Sarzaeem MM, Razi M, Kazemian G, Moghaddam ME, Rasi AM, Karimi M. Comparing efficacy of three methods of tranexamic acid administration in reducing hemoglobin drop following total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1521-4. doi: 10.1016/j.arth.2014.02.031. Epub 2014 Mar 6.
- Background: PubMed 24196467Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.
- Background: PubMed 24971180Pace TB, Foret JL, Palmer MJ, Tanner SL, Snider RG. Intraoperative platelet rich plasma usage in total knee arthroplasty: does it help? ISRN Orthop. 2013 Jul 28;2013:740173. doi: 10.1155/2013/740173. eCollection 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Vilchez, MD, PHD principal investigator
Hospital Universitario, Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group 1 Tranexamic Acid and Group 2 Platelet rich plasma in people with Osteoarthritis, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Effect on Hemoglobin Level (time frame: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02650856, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.