ArthrosisPhase 2TRANEXTKANCT02323373
Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty
A Phase 2 study testing Tranexamic Acid - topical and Tranexamic Acid - intravenous in people with Arthrosis, run by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Trial summary
This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthrosis
- What is being tested?
- Tranexamic Acid - topical and Tranexamic Acid - intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Nov 2014
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- history or identified risk for deep vein thrombosis or pulmonary embolism
- history of coagulation or cardiovascular disorders
- vascular diseases
- pregnancy
- current use of anticoagulation drugs
- previous orthopedic surgery in the legs.
About this study
Official title: Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients
This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.
Read the detailed description
Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.
The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.
Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.
- Conditions
- Arthrosis
- Being tested
- Tranexamic Acid - topical, Placebo, Tranexamic Acid - intravenous
- Keywords
- Arthroplasty, Replacement, Knee, Tranexamic Acid, Drug Administration Routes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid - topicalDrug
Also called trans-4-(aminomethyl)cyclohexanecarboxylic acid
Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.
PlaceboDrug
Also called Saline solution
100 ml of saline solution administered with anesthesia during 10 minutes
Tranexamic Acid - intravenousDrug
Also called trans-4-(aminomethyl)cyclohexanecarboxylic acid
Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Topical group | Experimental | Intervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release. Receives: Drug: Tranexamic Acid - topical |
| Intravenous group | Active comparator | Intervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes. Receives: Drug: Tranexamic Acid - intravenous |
| Placebo | Placebo comparator | Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Volume of blood loss in the suction drain device after TKA surgery
Measured: up to 48 hours from the end of surgery, with drained volume registered every 6 hours.
Secondary outcomes (2)
Thrombosis
Patients with events of thrombosis after TKA
Measured: up to 15 days after surgery
Need for transfusion
Number (or percentage) of patients requiring transfusion in TKA surgery
Measured: during or after surgery, during hospital stay (hospital discharge took place in four days, in average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Zekcer, Irmandade da Santa Casa de Misericordia de Sao Paulo
- Investigators
- Zekcer Ari, MD, PhD, Principal investigator, Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323373
- Sponsor's protocol ID
- ISCMSP
- Acronym
- TRANEXTKA
- Status last verified
- Jan 2015
- First submitted
- 10 Dec 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients
- ClinicalTrials.gov ID
- NCT02323373
- Acronym / sponsor ID
- TRANEXTKA / ISCMSP
- Conditions
- Arthrosis
- Keywords
- Arthroplasty, Replacement, Knee, Tranexamic Acid, Drug Administration Routes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao PauloUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Dec 2014 (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.
This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.
Detailed description
Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.
The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.
Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical group | Experimental | Drug: Tranexamic Acid - topicalIntervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release. |
| Intravenous group | Active comparator | Drug: Tranexamic Acid - intravenousIntervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboIntervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- history or identified risk for deep vein thrombosis or pulmonary embolism
- history of coagulation or cardiovascular disorders
- vascular diseases
- pregnancy
- current use of anticoagulation drugs
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 |
|---|---|---|
| Tranexamic Acid - topicalAlso: trans-4-(aminomethyl)cyclohexanecarboxylic acidTranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound. | Drug | Topical group |
| PlaceboAlso: Saline solution100 ml of saline solution administered with anesthesia during 10 minutes | Drug | Placebo |
| Tranexamic Acid - intravenousAlso: trans-4-(aminomethyl)cyclohexanecarboxylic acidTranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously. | Drug | Intravenous group |
Primary outcome
Blood loss
Time frame: up to 48 hours from the end of surgery, with drained volume registered every 6 hours.
Volume of blood loss in the suction drain device after TKA surgery
2 secondary outcomes
Thrombosis
Time frame: up to 15 days after surgery
Need for transfusion
Time frame: during or after surgery, during hospital stay (hospital discharge took place in four days, in average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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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.
Zekcer Ari, MD, PhD principal investigator
Santa Casa de São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid - topical and Tranexamic Acid - intravenous in people with Arthrosis, run by Irmandade da Santa Casa de Misericordia de Sao Paulo.
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 0 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 14 Jan 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood loss (time frame: up to 48 hours from the end of surgery, with drained volume registered every 6 hours.). 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 14 Jan 2015.