Total Blood LossPhase 4NCT03310060
Reducing Blood Loss Using Tisseel in TKA
A Phase 4 study testing Tisseel and Tranexamic Acid in people with Total Blood Loss, run by Chang Gung Memorial Hospital.
Trial summary
The purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topical hemostatic agents in patients receiving primary TKA procedures. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Blood Loss
- What is being tested?
- Tisseel and Tranexamic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 31 Dec 2018
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk with advanced knee osteoarthritis who was failure of medical treatment or rehabilitation and within age limit
Who cannot join
- Preoperative Hemoglobin ≦12 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
About this study
Official title: Reducing Blood Loss During Total Knee Arthroplasty Using Tisseel: A Prospective Randomized Control Trial
The purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topical hemostatic agents in patients receiving primary TKA procedures. The investigators will also observe if there is increased risk of blood transfusion rate by using topical hemostatic agents or not.
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 6% 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. 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, the safety to use TXA systemically in TKAs especially in high risk patients remains controversial. 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 their 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.
The investigators believe the use of hemostatic agent topically 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). On the other hand, thrombin-based hemostatic agents, Tisseel®, 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 Tisseel® 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 Tisseel® does not reduce blood loss in TKA procedures.
The purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topic hemostatic agents and their safety in a primary TKA procedures in patients with risk of thromboembolic events. The first group by topical Tisseel and intravenous TXA application, and the second group of placebo IV TXA then observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement among different groups.
- Conditions
- Total Blood Loss
- Being tested
- Tisseel, Tranexamic Acid
- Medical subject headings
- Exsanguination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TisseelDrug
Also called Fibrin Sealant
Tisseel® (Fibrin Sealant, 4ml, 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 4 mL vial containing the active product was used
Tranexamic AcidDrug
Also called Transamin
Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Tisseel combined Tranexamic acid | Active comparator | Drug: Tisseel® Applied on potential bleeding sites. The entire content was 4 mL.
Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery Receives: Drug: Tisseel; Drug: Tranexamic Acid |
| Tranexamic acid | Placebo comparator | Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery Receives: Drug: Tranexamic Acid |
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
Secondary outcomes (4)
Incidence of any thrombotic events
the composite of any suspected venous thromboembolism events, ischemic heart diseases, or cerebrovascular accidents
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
Blood transfusion requirement
compare blood transfusion requirement between two groups
Measured: from the operation to postoperative day 14
Calculated blood loss from drainage
blood loss was calculated according to the hemovac drainage record every eight hours after operation until removal.
Measured: from the operation to the postoperative day 2 until drainage removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Blood LossStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310060
- Sponsor's protocol ID
- 201700271A3
- Status last verified
- Sep 2017
- First submitted
- 2 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Blood Loss During Total Knee Arthroplasty Using Tisseel: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03310060
- Acronym / sponsor ID
- 201700271A3
- Conditions
- Total Blood Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 16 Oct 2017 (actual)
- 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.
The purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topical hemostatic agents in patients receiving primary TKA procedures. The investigators will also observe if there is increased risk of blood transfusion rate by using topical hemostatic agents or not.
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 6% 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. 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, the safety to use TXA systemically in TKAs especially in high risk patients remains controversial. 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 their 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.
The investigators believe the use of hemostatic agent topically 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). On the other hand, thrombin-based hemostatic agents, Tisseel®, 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 Tisseel® 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 Tisseel® does not reduce blood loss in TKA procedures.
The purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topic hemostatic agents and their safety in a primary TKA procedures in patients with risk of thromboembolic events. The first group by topical Tisseel and intravenous TXA application, and the second group of placebo IV TXA then observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement among different groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tisseel combined Tranexamic acid | Active comparator | Drug: Tisseel, Drug: Tranexamic AcidDrug: Tisseel® Applied on potential bleeding sites. The entire content was 4 mL. Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery |
| Tranexamic acid | Placebo comparator | Drug: Tranexamic AcidDrug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk with advanced knee osteoarthritis who was failure of medical treatment or rehabilitation and within age limit
Key exclusion criteria (1 listed)
- Preoperative Hemoglobin ≦12 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 |
|---|---|---|
| TisseelAlso: Fibrin SealantTisseel® (Fibrin Sealant, 4ml, 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 4 mL vial containing the active product was used | Drug | Tisseel combined Tranexamic acid |
| Tranexamic AcidAlso: TransaminDrug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery | Drug | Tisseel combined Tranexamic acid, Tranexamic acid |
Primary outcome
Total blood loss after operation
Time frame: from the operation to the postoperative day 3
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
4 secondary outcomes
Incidence of any thrombotic events
Time frame: within 30 days of the operation
Incidence of wound infection after surgery
Time frame: within 30 days of the operation
Blood transfusion requirement
Time frame: from the operation to postoperative day 14
Calculated blood loss from drainage
Time frame: from the operation to the postoperative day 2 until drainage removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tisseel and Tranexamic Acid in people with Total Blood Loss, run by Chang Gung Memorial Hospital.
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 1 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Total blood loss after operation (time frame: from the operation to the postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2017.