A Phase 4 interventional study of Topical tranexamic acid and Floseal® in Osteoarthritis, Knee, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Chang Gung Memorial Hospital · Phase 4, Interventional, and Prevention
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Among 14 studies in Osteoarthritis, Knee by Chang Gung Memorial Hospital — 2 open to participants now, 2 under way, 1 of them phase 3. Osteoarthritis, Knee · Chang Gung Memorial Hospital.
Among the 14 studies in Osteoarthritis, Knee by Chang Gung Memorial Hospital, this one is the 11th largest by enrollment, is one of 2 that started in 2017, is one of 4 in phase 4, and was the 6th registered.
3,294 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →2 of the 14 studies in Osteoarthritis, Knee by Chang Gung Memorial Hospital are open now, in 1 country. Recruiting first, the newest first:
Chang Gung Memorial Hospital · Sites in Taiwan
Ages 18–80
Chang Gung Memorial Hospital
By country, each count listing its studies:
Of the 383 Osteoarthritis, Knee studies recruiting now, 177 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 50 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 2 · Phase 4 4
First in 2010; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 70 is close to the median of 68 across 2,716 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 90 across the 14 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
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Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Osteoarthritis, Knee by Chang Gung Memorial Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure
Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. 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%. There were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients.
Besides, thrombin-based hemostatic agents, Floseal®(Baxter, Deerfield, Illinois), have been widely used in surgical procedure. Some recent studies demonstrated that topical use of Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA. But other studies showed Floseal® does not reduce blood loss in TKA procedures.
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. The blood saving effect of topical application of TXA in primary TKA was similar with systemic administration. The mean total blood loss of topical route of TXA inTKA patients was 940-1295 ml in different reports which was still high for patients with high thromboembolic risks. However, the efficacy and safety of topical use of TXA in TKA patients with history of thromboembolic disease is still unclear. A more effective regimen for bleeding prophylaxis afer primary TKA is necessary.
We believe that combined topical applications of two hemostatic agents of different mechanisms can bring a synergistic effect in blood saving and does not increase the risk of thromboembolic disease after TKA.
Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Drug: Topical tranexamic acid · Drug: Floseal® · Drug: rivaroxaban (10mg)
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Drug: Topical tranexamic acid · Drug: rivaroxaban (10mg)
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Also known as: Topical transamine
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)
Also known as: Thrombin-gelatin matrix
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Also known as: Xarelto
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
Time frame: From the operation to the postoperative day 3 or 4
Blood Transfusion Rate
We will record the event of blood transfusion, and calculate the incidence of transfusion
Time frame: From the operation to the postoperative day 3 or 4
Incidence of Thrombosis Events
The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents
Time frame: within 30 days of the operation
Between September 2017 and September 2018, a consecutive series of 125 patients who underwent unilateral TKA were assessed in terms of their eligibility for inclusion for this study. 35 patients were excluded based on the exclusion criteria, eight patients did not withhold antiplatelet drugs or anticoagulants 7 days before surgery, and 12 other patients declined to participate in the study. Total 70 patients were enrolled and randomly assigned into 2 groups
| Milestone | Combined Topical TXA and Floseal | Topical TXA Alone |
|---|---|---|
| Started | 35 | 35 |
| Completed | 35 | 34 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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
| ml | Combined Topical TXA and Floseal | Topical TXA Alone |
|---|---|---|
| Total Blood Loss After Operation | 678 ± 203 | 733 ± 217 |
We will record the event of blood transfusion, and calculate the incidence of transfusion
| Participants | Combined Topical TXA and Floseal | Topical TXA Alone |
|---|---|---|
| Blood Transfusion Rate | 1 | 0 |
The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents
| Participants | Combined Topical TXA and Floseal | Topical TXA Alone |
|---|---|---|
| Incidence of Thrombosis Events | 0 | 0 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combined Topical TXA and Floseal | 0/35 (0%) | 0/35 (0%) | 17/35 (48.6%) |
| Topical TXA Alone | 0/34 (0%) | 0/34 (0%) | 15/34 (44.1%) |
| Event | Combined Topical TXA and Floseal | Topical TXA Alone |
|---|---|---|
| EcchymosisSurgical and medical procedures | 17/35 | 15/34 |
| Age, Continuous(years) | Combined Topical TXA and Floseal | Topical TXA Alone | Total |
|---|---|---|---|
| Mean | 69.26 ± 5.88 | 67.47 ± 4.00 | 68.38 ± 4.32 |
| Sex: Female, Male(Participants) | Combined Topical TXA and Floseal | Topical TXA Alone | Total |
|---|---|---|---|
| Female | 24 | 29 | 53 |
| Male | 11 | 5 | 16 |
| Race (NIH/OMB)(Participants) | Combined Topical TXA and Floseal | Topical TXA Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 35 | 34 | 69 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Combined Topical TXA and Floseal | Topical TXA Alone | Total |
|---|---|---|---|
| Taiwan | 35 | 34 | 69 |
| Body mass index(kg/m^2) | Combined Topical TXA and Floseal | Topical TXA Alone | Total |
|---|---|---|---|
| Mean | 28.69 ± 3.77 | 27.44 ± 4.44 | 28.07 ± 4.11 |
| Preop Hb(g/dL) | Combined Topical TXA and Floseal | Topical TXA Alone | Total |
|---|---|---|---|
| Mean | 13.79 ± 1.39 | 13.39 ± 0.85 | 13.61 ± 1.03 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The datasets used and analyzed in the study are available on request to the corresponding author
Ran from Sep 2017 to primary completion in Sep 2018, 12 months.
Results were first posted in Aug 2021, 2 years 10 months after primary completion.
Of 88 non-industry phase 4 interventional studies under Osteoarthritis, Knee, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 32. This study's 12 months is below that.
Counting every sponsor, half of 97 studies reached it within 19 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FloSeal Matrix
Chang Gung Memorial Hospital →