Blood LossPhase 3TRANEX1NCT01881568
Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA
A Phase 3 study testing Tranexamic Acid in people with Blood Loss, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jan 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
- Patients for La Paz- Cantoblanco Hospital, Madrid, Spain
Who cannot join
- Patients that refuse to sign the Inform Consent
- Allergy to tranexamic acid
- Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine>2mg/dL if mens and >1.8mg/dL if woman); or hepatic disfunction.
- Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged PPT(>1.4 x normal)
- History of thromboembolic disease: CVA, DVT, PE
- Blood dyscrasias
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- Retinopathy (disturbances of color vision)
- Jehovah's witnesses
- Pregnancy
- Breastfeeding
- Been participating or been participated a year ago in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.
The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).
Read the detailed description
The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.
- Conditions
- Blood Loss
- Being tested
- Tranexamic Acid
- Keywords
- Total Knee Arthroplasty, TKA, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called AMCHAFIBRIN
Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
Tranexamic AcidDrug
Also called AMCHAFIBRIN,
Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 1. Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow:
* 50mL by irrigation before wound closure
* 50mL by intraarticular administration (Drenofast) after wound closure.
2. Intravenous administration of Normal saline (0.9% sodium chloride) as follow:
* 100mL before tourniquet realised
* 100mL 3 hours after surgery Receives: Drug: Tranexamic Acid |
| Comparator | Active comparator | 1. Topical administration of Normal saline (0.9% sodium chloride) as follow:
* 50mL by irrigation before wound closure
* 50mL by intraarticular administration (Drenofast) after wound closure
2. Intravenous administration of two dosis of Tranexamic Acid as follow:
* 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised
* 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 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.
Blood transfusion rate
Number of transfused patients in each arm/Total number of patients in each arm
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (8)
Visible blood loss
Number of milliliters drained in Redon after 24 hours post OP
Measured: 24 hours after surgery
Invisible blood loss
Number of milliliters estimated with Nedler formula 48 hours after surgery. Invisible blood loss= 75*weight(Kg)*[(Hb0-Hb1)/Hb0]+ blood transfused(mL)
Measured: 48 hours after surgery
Surgery infection rate
- Percent of patients with proved signs of infection during the hospital stay
- Percent of patients with proved signs of infection one month after surgery(safety reasons)
Measured: One month after surgery
Range of motion
- Range (in degrees) from full extension to full flexion during the hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Prevalence of drug-related adverse events
Rate and characteristics of the adverse events during the hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of PE
- Percent of PE during the hospital stay
- Percent of PE one month after surgery(safety reasons)
Measured: One month after surgery
Rate of DVT
- Percent of DVT during the hospital stay
- Percent of DVT one month after surgery(safety reasons)
Measured: One month after surgery
Rate or Thrombophlebitis
- Percent of Thrombophlebitis during the hospital stay
- Percent of Thrombophlebitis one month after surgery(safety reasons)
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Gómez Barrena, Hospital Universitario La Paz
- Investigators
- Enrique Gomez Barrena, PI, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881568
- Sponsor's protocol ID
- TRANEX1
- Acronym
- TRANEX1
- Status last verified
- Dec 2014
- First submitted
- 5 Feb 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 25471907
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.
- ClinicalTrials.gov ID
- NCT01881568
- Acronym / sponsor ID
- TRANEX1 / TRANEX1
- Conditions
- Blood Loss
- Keywords
- Total Knee Arthroplasty, TKA, blood loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 19 Jun 2013 (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.
The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).
Detailed description
The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Tranexamic Acid1. Topical administration of 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) as follow: * 50mL by irrigation before wound closure * 50mL by intraarticular administration (Drenofast) after wound closure. 2. Intravenous administration of Normal saline (0.9% sodium chloride) as follow: * 100mL before tourniquet realised * 100mL 3 hours after surgery |
| Comparator | Active comparator | Drug: Tranexamic Acid1. Topical administration of Normal saline (0.9% sodium chloride) as follow: * 50mL by irrigation before wound closure * 50mL by intraarticular administration (Drenofast) after wound closure 2. Intravenous administration of two dosis of Tranexamic Acid as follow: * 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), before tourniquet realised * 15mg/kg of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride), 3 hours after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
- Patients for La Paz- Cantoblanco Hospital, Madrid, Spain
Key exclusion criteria (11 listed)
- Patients that refuse to sign the Inform Consent
- Allergy to tranexamic acid
- Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine>2mg/dL if mens and >1.8mg/dL if woman); or hepatic disfunction.
- Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged PPT(>1.4 x normal)
- History of thromboembolic disease: CVA, DVT, PE
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 AcidAlso: AMCHAFIBRINTopical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride) | Drug | Experimental |
| Tranexamic AcidAlso: AMCHAFIBRIN,Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each) | Drug | Comparator |
Primary outcome
Blood transfusion rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of transfused patients in each arm/Total number of patients in each arm
8 secondary outcomes
Visible blood loss
Time frame: 24 hours after surgery
Invisible blood loss
Time frame: 48 hours after surgery
Surgery infection rate
Time frame: One month after surgery
Range of motion
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Prevalence of drug-related adverse events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of PE
Time frame: One month after surgery
Rate of DVT
Time frame: One month after surgery
Rate or Thrombophlebitis
Time frame: One month after surgery
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 3 Dec 2014.
- Derived from this study: 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.
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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.
Enrique Gomez Barrena, PI principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid in people with Blood Loss, run by Hospital Universitario La Paz at 1 site in Spain.
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 3 inclusion and 11 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 3 Dec 2014. 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 Spain. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 transfusion rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days). 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 NCT01881568, which also lists 1 linked publication.
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 3 Dec 2014.