Knee Arthroplasty, TotalNCT02327117
Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial
A study testing Tranexamic Acid and Normal saline in people with Knee Arthroplasty, Total, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Tranexamic Acid and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals with osteoarthritis who indicated for primary TKA.
Who cannot join
- Previous history of ceberovascular diseases
- Previous history of myocardial infarction
- Candidates for bilateral TKA
Trial locations and contacts
1 site in 1 country.
About this study
Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Tranexamic Acid, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic Acid |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb Level 48 Hours After Total Knee Arthroplasty
Measured: 48 hours after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2015
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.
- Other trials for Knee Arthroplasty, TotalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Nemati, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327117
- Sponsor's protocol ID
- 392114
- Status last verified
- Jun 2016
- First submitted
- 23 Dec 2014
- Last updated
- 22 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02327117
- Acronym / sponsor ID
- 392114
- Conditions
- Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 22 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid |
| Normal Saline | Placebo comparator | Drug: Normal saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with osteoarthritis who indicated for primary TKA.
Key exclusion criteria (3 listed)
- Previous history of ceberovascular diseases
- Previous history of myocardial infarction
- Candidates for bilateral TKA
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 | Drug | Tranexamic acid |
| Normal saline | Drug | Normal Saline |
Primary outcome
Hb Level 48 Hours After Total Knee Arthroplasty
Time frame: 48 hours after TKA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Knee Arthroplasty, Total
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Normal saline in people with Knee Arthroplasty, Total, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 3 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 22 Jul 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 Iran. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2016). 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?
Hb Level 48 Hours After Total Knee Arthroplasty (time frame: 48 hours after TKA). 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 22 Jul 2016.