Osteoarthritis, KneePhase 4NCT02865174
Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty
A Phase 4 study testing Topical tranexamic acid, Floseal® and Enoxaparin in people with Osteoarthritis, Knee, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Our purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topical hemostatic agents in primary TKA procedures in patients with a risk of thromboembolic events. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Topical tranexamic acid, Floseal® and Enoxaparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2016to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of ischemic heart disease, stroke, or VTE high risk group, such as obesity, varicose vein of the leg, previous history of PE or DVT, hypercoagulability, recent or ongoing treatment for cancer.
- After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk Advanced knee osteoarthritis, Failure of medical treatment or rehabilitation. Hemoglobin > 11g/dl, No use of non-steroid anti-inflammatory agent one week before operation
Who cannot join
- Preoperative Hemoglobin ≦11 g/dl History of infection or intraarticular fracture of the affective knee Renal function deficiency (GFR < 30 ml/min/1.73m2) Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Topical Tranexamic Acid and Floseal® on Blood Loss After Total Knee Arthroplasty in Patients With a Thromboembolic Risk
Our purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topical hemostatic agents in primary TKA procedures in patients with a risk of thromboembolic events. We will also observe if there is increased risk of thromboembolism by use of topical hemostatic agents.
Read the detailed description
Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Previous studies demonstrated a transfusion rates ranging from 10% to 38% after standard TKAs. Transfusion carries significant risks of cardiopulmonary embarrassment, disease transmission, immunological reaction and postoperative infection.
The major causes of postoperative blood loss following TKA are attributed to surgery itself which induces a considerable activation of the coagulation cascade and local fibrinolysis, the latter is further enhanced after release of the tourniquet at the end of surgery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effective reducing blood loss after standard TKA. Our previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery. A recent study by Nishihara et al demonstrated that use of TXA in total hip arthroplasty did not appear to affect the prevalence of either proximal DVT or PE. Another study by Xie J et al also showed the incidence of postoperative VTE was unchanged when TXA was administered in primary unilateral TKA, but in there study the total occurrence of vascular occlusive events was statistically significantly higher (17.55% Vs 9.35%, p < 0.001) in the TXA group. However, in this two studies the patient with high risk of thromboembolic events (ischemic heart disease, chronic renal failure on hemodialysis, cerebral infarction, previous VTE disease, thrombophilia associated with genetic diseases) were excluded.
We believe the topical use of hemostatic agent in patients with high risk of thromboembolism can avoid its systematic effect and decrease its potential perioperative risk of thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary embolism). Recently, there were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. Besides, thrombin-based hemostatic agents, Floseal®, have been widely used in surgical procedure including gynecology, general surgery, and orthopedics which were still attracting the attention and interest of multitudinous surgeons. Some recent studies demonstrated that topic use of Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA and is not related to adverse reactions or complications such as wound infection, venous thromboembolism events(VTE). But there were another studies showed Floseal® does not reduce blood loss in TKA procedures.
Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topic hemostatic agents and their safety in a primary TKA procedures in patients with risk of thromboembolic events. The first group by topical TXA application, the second group by topical Floseal® application, and the third group of placebo and observe whether there is difference in the the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement among these patient groups.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Topical tranexamic acid, Floseal®, Enoxaparin
- Keywords
- Thrombin-gelatin matrix, Floseal, Tranexamic Acid, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical tranexamic acidDrug
Also called Topical transamine
Intraarticular application of tranexamic acid 3g in 100 ml normal saline into knee joint after closure of the joint capsule
Floseal®Drug
Also called Thrombin-gelatin matrix
Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
EnoxaparinDrug
Also called Low molecular weight heparin
Enoxaparin will be administrated sc 40mg each day postoperatively as venous thromboembolism prophylaxis in the duration of hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Topical tranexamic acid | Active comparator | Intraarticular application of tranexamic acid Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay Receives: Drug: Topical tranexamic acid; Drug: Enoxaparin |
| Floseal® | Active comparator | Floseal® was applied on potential bleeding sites before prosthesis implantation.
Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay Receives: Drug: Floseal®; Drug: Enoxaparin |
| Control group | Placebo comparator | No intervention before closure of joint capsule. Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss after operation
Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x [change in Hb level / preoperative Hb level])x1000+volume transfused
Measured: From the operation to the postoperative day 3 or 4
Decrease of hemoglobin level after operation
We will check hemoglobin preoperatively and postop. Day 1, 2, 3 or 4 and 14. We will calculate the change of hemoglobin level on postoperative day 1, 2, 4, and 14.
Measured: From the operation to the postoperative day 14
Secondary outcomes (4)
Incidence of major postoperative bleeding
Major bleeding was defined as bleeding that involved a critical organ, or that required reoperation or clinically overt bleeding outside the surgical site that was associated with a decrease in the hemoglobin level of 2 g or more per deciliter or requiring infusion of 2 or more units of blood
Measured: within 30 days of the operation
Incidence of any non-major bleeding
Non-major bleeding including hemorrhagic wound complications (excessive wound hematoma or bleeding at the surgical site
Measured: within 30 days of the operation
Incidence of wound infection after surgery
composite of wound poor healing, superficial wound infection, and deep infection requiring return to surgery
Measured: within 30 days of the operation
Incidence of any thrombotic events
the composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents
Measured: within 30 days of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jun-Wen, Chang Gung Memorial Hospital
- Investigators
- Jun-Wen Wang, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865174
- Sponsor's protocol ID
- NMMRPG8F0191
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.
PubMed 25471907Schwab PE, Thienpont E. Use of a haemostatic matrix does not reduce blood loss in minimally invasive total knee arthroplasty. Blood Transfus. 2015 Jul;13(3):435-41. doi: 10.2450/2015.0199-14. Epub 2015 Jan 26.
PubMed 25761324Helito CP, Gobbi RG, Castrillon LM, Hinkel BB, Pecora JR, Camanho GL. Comparison of Floseal(r) and electrocautery in hemostasis after total knee arthroplasty. Acta Ortop Bras. 2013;21(6):320-2. doi: 10.1590/S1413-78522013000600004.
PubMed 24453689Comadoll JL, Comadoll S, Hutchcraft A, Krishnan S, Farrell K, Kreuwel HT, Bechter M. Comparison of hemostatic matrix and standard hemostasis in patients undergoing primary TKA. Orthopedics. 2012 Jun;35(6):e785-93. doi: 10.3928/01477447-20120525-14.
PubMed 22691647Kim HJ, Fraser MR, Kahn B, Lyman S, Figgie MP. The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jul 3;94(13):1160-5. doi: 10.2106/JBJS.K.00531.
PubMed 22623075Suarez JC, Slotkin EM, Alvarez AM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostatic agent in total knee arthroplasty. J Arthroplasty. 2014 Oct;29(10):1950-5. doi: 10.1016/j.arth.2014.05.025. Epub 2014 Jun 5.
PubMed 25015756Di Francesco A, Flamini S, Fiori F, Mastri F. Hemostatic matrix effects on blood loss after total knee arthroplasty: A randomized controlled trial. Indian J Orthop. 2013 Sep;47(5):474-81. doi: 10.4103/0019-5413.118203.
PubMed 24133307Testini M, Marzaioli R, Lissidini G, Lippolis A, Logoluso F, Gurrado A, Lardo D, Poli E, Piccinni G. The effectiveness of FloSeal matrix hemostatic agent in thyroid surgery: a prospective, randomized, control study. Langenbecks Arch Surg. 2009 Sep;394(5):837-42. doi: 10.1007/s00423-009-0497-5. Epub 2009 May 7.
PubMed 19421770Clapp M, Huang JC. Use of FloSeal Sealant in the Surgical Management of Tubal Ectopic Pregnancy. Case Rep Obstet Gynecol. 2013;2013:906825. doi: 10.1155/2013/906825. Epub 2013 May 29.
PubMed 23819082Gazzeri R, Galarza M, Alfier A. Safety biocompatibility of gelatin hemostatic matrix (Floseal and Surgiflo) in neurosurgical procedures. Surg Technol Int. 2012 Dec;22:49-54.
PubMed 22915500Georgiadis 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 23906869Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.
PubMed 23886406Chimento 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 24034510Wind 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 23541868Yen SH, Lin PC, Wu CT, Wang JW. Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial. Biomed Res Int. 2021 Jan 14;2021:2549521. doi: 10.1155/2021/2549521. eCollection 2021.
PubMed 33511201
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Tranexamic Acid and Floseal® on Blood Loss After Total Knee Arthroplasty in Patients With a Thromboembolic Risk
- ClinicalTrials.gov ID
- NCT02865174
- Acronym / sponsor ID
- NMMRPG8F0191
- Conditions
- Osteoarthritis, Knee
- Keywords
- Thrombin-gelatin matrix, Floseal, Tranexamic Acid, Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topical hemostatic agents in primary TKA procedures in patients with a risk of thromboembolic events. We will also observe if there is increased risk of thromboembolism by use of topical hemostatic agents.
Detailed description
Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Previous studies demonstrated a transfusion rates ranging from 10% to 38% after standard TKAs. Transfusion carries significant risks of cardiopulmonary embarrassment, disease transmission, immunological reaction and postoperative infection.
The major causes of postoperative blood loss following TKA are attributed to surgery itself which induces a considerable activation of the coagulation cascade and local fibrinolysis, the latter is further enhanced after release of the tourniquet at the end of surgery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effective reducing blood loss after standard TKA. Our previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery. A recent study by Nishihara et al demonstrated that use of TXA in total hip arthroplasty did not appear to affect the prevalence of either proximal DVT or PE. Another study by Xie J et al also showed the incidence of postoperative VTE was unchanged when TXA was administered in primary unilateral TKA, but in there study the total occurrence of vascular occlusive events was statistically significantly higher (17.55% Vs 9.35%, p < 0.001) in the TXA group. However, in this two studies the patient with high risk of thromboembolic events (ischemic heart disease, chronic renal failure on hemodialysis, cerebral infarction, previous VTE disease, thrombophilia associated with genetic diseases) were excluded.
We believe the topical use of hemostatic agent in patients with high risk of thromboembolism can avoid its systematic effect and decrease its potential perioperative risk of thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary embolism). Recently, there were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. Besides, thrombin-based hemostatic agents, Floseal®, have been widely used in surgical procedure including gynecology, general surgery, and orthopedics which were still attracting the attention and interest of multitudinous surgeons. Some recent studies demonstrated that topic use of Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA and is not related to adverse reactions or complications such as wound infection, venous thromboembolism events(VTE). But there were another studies showed Floseal® does not reduce blood loss in TKA procedures.
Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topic hemostatic agents and their safety in a primary TKA procedures in patients with risk of thromboembolic events. The first group by topical TXA application, the second group by topical Floseal® application, and the third group of placebo and observe whether there is difference in the the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement among these patient groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical tranexamic acid | Active comparator | Drug: Topical tranexamic acid, Drug: EnoxaparinIntraarticular application of tranexamic acid Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay |
| Floseal® | Active comparator | Drug: Floseal®, Drug: EnoxaparinFloseal® was applied on potential bleeding sites before prosthesis implantation. Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay |
| Control group | Placebo comparator | Drug: EnoxaparinNo intervention before closure of joint capsule. Enoxaparin for venous thromboembolism prophylaxis in the duration of hospital stay |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of ischemic heart disease, stroke, or VTE high risk group, such as obesity, varicose vein of the leg, previous history of PE or DVT, hypercoagulability, recent or ongoing treatment for cancer.
- After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk Advanced knee osteoarthritis, Failure of medical treatment or rehabilitation. Hemoglobin > 11g/dl, No use of non-steroid anti-inflammatory agent one week before operation
Key exclusion criteria (1 listed)
- Preoperative Hemoglobin ≦11 g/dl History of infection or intraarticular fracture of the affective knee Renal function deficiency (GFR < 30 ml/min/1.73m2) Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy
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 |
|---|---|---|
| Topical tranexamic acidAlso: Topical transamineIntraarticular application of tranexamic acid 3g in 100 ml normal saline into knee joint after closure of the joint capsule | Drug | Topical tranexamic acid |
| Floseal®Also: Thrombin-gelatin matrixFloseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter) | Drug | Floseal® |
| EnoxaparinAlso: Low molecular weight heparinEnoxaparin will be administrated sc 40mg each day postoperatively as venous thromboembolism prophylaxis in the duration of hospital stay | Drug | Control group, Floseal®, Topical tranexamic acid |
Primary outcome
Total blood loss after operation
Time frame: From the operation to the postoperative day 3 or 4
Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x [change in Hb level / preoperative Hb level])x1000+volume transfused
Decrease of hemoglobin level after operation
Time frame: From the operation to the postoperative day 14
We will check hemoglobin preoperatively and postop. Day 1, 2, 3 or 4 and 14. We will calculate the change of hemoglobin level on postoperative day 1, 2, 4, and 14.
4 secondary outcomes
Incidence of major postoperative bleeding
Time frame: within 30 days of the operation
Incidence of any non-major bleeding
Time frame: within 30 days of the operation
Incidence of wound infection after surgery
Time frame: within 30 days of the operation
Incidence of any thrombotic events
Time frame: within 30 days of the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Background: PubMed 25471907Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.
- Background: PubMed 25761324Schwab PE, Thienpont E. Use of a haemostatic matrix does not reduce blood loss in minimally invasive total knee arthroplasty. Blood Transfus. 2015 Jul;13(3):435-41. doi: 10.2450/2015.0199-14. Epub 2015 Jan 26.
- Background: PubMed 24453689Helito CP, Gobbi RG, Castrillon LM, Hinkel BB, Pecora JR, Camanho GL. Comparison of Floseal(r) and electrocautery in hemostasis after total knee arthroplasty. Acta Ortop Bras. 2013;21(6):320-2. doi: 10.1590/S1413-78522013000600004.
- Background: PubMed 22691647Comadoll JL, Comadoll S, Hutchcraft A, Krishnan S, Farrell K, Kreuwel HT, Bechter M. Comparison of hemostatic matrix and standard hemostasis in patients undergoing primary TKA. Orthopedics. 2012 Jun;35(6):e785-93. doi: 10.3928/01477447-20120525-14.
- Background: PubMed 22623075Kim HJ, Fraser MR, Kahn B, Lyman S, Figgie MP. The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jul 3;94(13):1160-5. doi: 10.2106/JBJS.K.00531.
- Background: PubMed 25015756Suarez JC, Slotkin EM, Alvarez AM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostatic agent in total knee arthroplasty. J Arthroplasty. 2014 Oct;29(10):1950-5. doi: 10.1016/j.arth.2014.05.025. Epub 2014 Jun 5.
- Background: PubMed 24133307Di Francesco A, Flamini S, Fiori F, Mastri F. Hemostatic matrix effects on blood loss after total knee arthroplasty: A randomized controlled trial. Indian J Orthop. 2013 Sep;47(5):474-81. doi: 10.4103/0019-5413.118203.
- Background: PubMed 19421770Testini M, Marzaioli R, Lissidini G, Lippolis A, Logoluso F, Gurrado A, Lardo D, Poli E, Piccinni G. The effectiveness of FloSeal matrix hemostatic agent in thyroid surgery: a prospective, randomized, control study. Langenbecks Arch Surg. 2009 Sep;394(5):837-42. doi: 10.1007/s00423-009-0497-5. Epub 2009 May 7.
- Background: PubMed 23819082Clapp M, Huang JC. Use of FloSeal Sealant in the Surgical Management of Tubal Ectopic Pregnancy. Case Rep Obstet Gynecol. 2013;2013:906825. doi: 10.1155/2013/906825. Epub 2013 May 29.
- Background: PubMed 22915500Gazzeri R, Galarza M, Alfier A. Safety biocompatibility of gelatin hemostatic matrix (Floseal and Surgiflo) in neurosurgical procedures. Surg Technol Int. 2012 Dec;22:49-54.
- 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 23886406Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.
- Individual participant dataSharing planned: Undecided
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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.
Jun-Wen Wang study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical tranexamic acid, Floseal® and Enoxaparin in people with Osteoarthritis, Knee, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Aug 2016. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun-Wen MD Wang (886-7-7317123, wangjw@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss after operation (time frame: From the operation to the postoperative day 3 or 4). The study lists 2 primary outcomes in all. 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 NCT02865174, which also lists 15 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 12 Aug 2016.