Blood LossPhase 3TRANEXTOPNCT01594671
Tranexamic Acid for Unilateral Total Knee Arthroplasty
A Phase 3 study testing Tranexamic Acid and haemostasia in people with Blood Loss, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical… 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 and haemostasia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2012to Oct 2012
- 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
- Unilateral Total knee arthroplasty
- The patient consent to participate
Who cannot join
- Antecedent of thromboembolic disease
- Patient with cardiac alterations of the rhythm
- Patients with valvular cardiac prosthesis
- Patients with pro-thrombotic alterations of coagulation
- Treatment with anticonceptive drugs
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Esperanza
Barcelona, Barcelona, 08024
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
About this study
Official title: Prevention of Postoperative Blood Loss: Randomised Multicentre Parallel Clinical Trial That Assess the Topical and Intravenous Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.
Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.
Read the detailed description
Objectives:
- Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.
- Secondary: To assess the treatment safety. To perform a cost- analyses.
Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.
Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".
Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).
Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis.
Substudy: Pharmacokinetic study. The first 24 patients included in "Hospital de la Santa Creu i Sant Pau" for tranexamic acid (12 topical- 12 intravenous) to determine:
- Plasmatic concentrations of tranexamic acid
- In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.
- Conditions
- Blood Loss
- Being tested
- Tranexamic Acid, haemostasia
- Keywords
- primary knee arthroplasty, tranexamic acid, topical
- 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
Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.
Each dosage: 2 ampoules of 500mg/5 mL/ampoule
Tranexamic AcidDrug
Also called Amchafibrin
One dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
haemostasiaOther
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.
Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin Receives: Drug: Tranexamic Acid; Other: haemostasia |
| Habitual haemostasia | Active comparator | The surgical habitual haemostasia. Receives: Other: haemostasia |
| Topical Tranexamic acid | Experimental | Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser. Receives: Drug: Tranexamic Acid; Other: haemostasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss (mL)
Blood will be collected by drainages during the first 24 hours after surgery.
Measured: at 24 hours postoperatively
Secondary outcomes (3)
Hidden blood loss
Hidden blood loss will be calculated by Nadler's formula
Measured: From admission to hospital until an average of 5 days postoperative period
Wound complications
We will quantify infections, haematomas and other complications related with surgery
Measured: 5 weeks postoperatively
Adverse effect related with the interventions
Any adverse effects related with tranexamic acid will be collected
Measured: 5 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aguilera X, M.D, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauMartinez-Zapata MJ, PhD, Study director, Centro Cochrane Iberoamericano. IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594671
- Sponsor's protocol ID
- IIBSP-ATR-2010-23
- Acronym
- TRANEXTOP
- Status last verified
- Dec 2012
- First submitted
- 3 May 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Blood Loss: Randomised Multicentre Parallel Clinical Trial That Assess the Topical and Intravenous Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT01594671
- Acronym / sponsor ID
- TRANEXTOP / IIBSP-ATR-2010-23
- Conditions
- Blood Loss
- Keywords
- primary knee arthroplasty, tranexamic acid, topical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 May 2012 (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.
Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.
Detailed description
Objectives:
- Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.
- Secondary: To assess the treatment safety. To perform a cost- analyses.
Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.
Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".
Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).
Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis.
Substudy: Pharmacokinetic study. The first 24 patients included in "Hospital de la Santa Creu i Sant Pau" for tranexamic acid (12 topical- 12 intravenous) to determine:
- Plasmatic concentrations of tranexamic acid
- In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid, Other: haemostasiaIntravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin |
| Habitual haemostasia | Active comparator | Other: haemostasiaThe surgical habitual haemostasia. |
| Topical Tranexamic acid | Experimental | Drug: Tranexamic Acid, Other: haemostasiaTopical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral Total knee arthroplasty
- The patient consent to participate
Key exclusion criteria (5 listed)
- Antecedent of thromboembolic disease
- Patient with cardiac alterations of the rhythm
- Patients with valvular cardiac prosthesis
- Patients with pro-thrombotic alterations of coagulation
- Treatment with anticonceptive 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 AcidAlso: AmchafibrinTwo dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage. Each dosage: 2 ampoules of 500mg/5 mL/ampoule | Drug | Tranexamic acid |
| Tranexamic AcidAlso: AmchafibrinOne dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser. | Drug | Topical Tranexamic acid |
| haemostasiaThe surgical habitual haemostasia: electrocoagulation of the bleeding tissues | Other | Habitual haemostasia, Topical Tranexamic acid, Tranexamic acid |
Primary outcome
Total blood loss (mL)
Time frame: at 24 hours postoperatively
Blood will be collected by drainages during the first 24 hours after surgery.
3 secondary outcomes
Hidden blood loss
Time frame: From admission to hospital until an average of 5 days postoperative period
Wound complications
Time frame: 5 weeks postoperatively
Adverse effect related with the interventions
Time frame: 5 weeks postoperatively
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 19 Dec 2012.
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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.
Aguilera X, M.D principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Martinez-Zapata MJ, PhD study director
Centro Cochrane Iberoamericano. IIB Sant Pau
2 sites 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 and haemostasia in people with Blood Loss, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites 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 2 inclusion and 5 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 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Total blood loss (mL) (time frame: at 24 hours postoperatively). 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 19 Dec 2012.