Knee ArthropathyPhase 3ATRHEMOSNCT01306370
Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
A Phase 3 study testing Tranexamic Acid, Fibrin glue and Habitual haemostasis in people with Knee Arthropathy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Objectives: a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee. Secondaries: To assess the treatment safety. To perform a cost- analyses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Tranexamic Acid, Fibrin glue and Habitual haemostasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Nov 2011
- 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
- Total knee arthroplasty
- The patient consent to participate
Who cannot join
- Intolerance drugs to the study or to bovine protein (aprotinin)
- 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
1 site in 1 country.
About this study
Official title: Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.
Objectives:
- Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.
Read more
Secondaries: To assess the treatment safety. To perform a cost- analyses.
Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.
Nº of participant centres: 1. Random allocation will be centralised.
Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.
Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.
Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.
Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.
- Conditions
- Knee Arthropathy
- Being tested
- Tranexamic Acid, Fibrin glue, Habitual haemostasis
- Keywords
- primary knee arthroplasty, fibrin glue, tranexamic acid, topic
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
Fibrin glueDrug
Also called Tissucol
Topical administration, before to close the surgical wound. Dosage: 2 mL.
Fibrin glueBiological
Topical administration, before to close the surgical wound.
Habitual haemostasisOther
The surgical habitual haemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid is a synthetic derivative of the amino acid lysine. It inhibits fibrinolysis by blocking the lysine binding sites on plasminogen and facilitates the coagulation process. Receives: Drug: Tranexamic Acid |
| Fibrin glue BSTC | Experimental | It is homologous fibrin glue from a single blood donor. Receives: Biological: Fibrin glue |
| Tissucol | Experimental | It is fibrin glue commercialized from multiple donors. Receives: Drug: Fibrin glue |
| Habitual haemostasis | Other | Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis) Receives: Other: Habitual haemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood loss (mL)
Blood loss (mL) by the surgical wound collected by drain systems.
Measured: During the first 48h after the surgical intervention
Secondary outcomes (9)
Percentage of patients that need a postoperative blood transfusion
Measured: During the first postoperative week
Percentage of patients with surgical wound infection
Measured: During the first postoperative month
Percentage of patients with surgical wound dehiscence
Measured: During the first postoperative month
Percentage of patients with re-intervention by wound complications
Measured: During the first postoperative month
Incidence of deep venous thrombosis
Measured: During the first postoperative week
Pain of surgical wound
Measured: During the first postoperative week
Units of blood transfusion
Measured: During the first postoperative week
hospital length stay
Measured: Days
Mortality
Measured: During the first postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Banc de Sang i Teixits
- Responsible party
- Sponsor
- Investigators
- Martinez Zapata, Mª José, Study director, Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant PauAguilera Roig, Xavier, Principal investigator, Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306370
- Sponsor's protocol ID
- 2009-017804-95
- Other IDs
- TRA-81, 2009
- Acronym
- ATRHEMOS
- Status last verified
- Aug 2013
- First submitted
- 28 Feb 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT01306370
- Acronym / sponsor ID
- ATRHEMOS / 2009-017804-95
- Conditions
- Knee Arthropathy
- Keywords
- primary knee arthroplasty, fibrin glue, tranexamic acid, topic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Banc de Sang i Teixits
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Mar 2011 (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.
Objectives:
- Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.
Secondaries: To assess the treatment safety. To perform a cost- analyses.
Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.
Nº of participant centres: 1. Random allocation will be centralised.
Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.
Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.
Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.
Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidTranexamic acid is a synthetic derivative of the amino acid lysine. It inhibits fibrinolysis by blocking the lysine binding sites on plasminogen and facilitates the coagulation process. |
| Fibrin glue BSTC | Experimental | Biological: Fibrin glueIt is homologous fibrin glue from a single blood donor. |
| Tissucol | Experimental | Drug: Fibrin glueIt is fibrin glue commercialized from multiple donors. |
| Habitual haemostasis | Other | Other: Habitual haemostasisElectrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Total knee arthroplasty
- The patient consent to participate
Key exclusion criteria (6 listed)
- Intolerance drugs to the study or to bovine protein (aprotinin)
- Antecedent of thromboembolic disease
- Patient with cardiac alterations of the rhythm
- Patients with valvular cardiac prosthesis
- Patients with pro-thrombotic alterations of coagulation
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 |
| Fibrin glueAlso: TissucolTopical administration, before to close the surgical wound. Dosage: 2 mL. | Drug | Tissucol |
| Fibrin glueTopical administration, before to close the surgical wound. | Biological | Fibrin glue BSTC |
| Habitual haemostasisThe surgical habitual haemostasis. | Other | Habitual haemostasis |
Primary outcome
Postoperative blood loss (mL)
Time frame: During the first 48h after the surgical intervention
Blood loss (mL) by the surgical wound collected by drain systems.
9 secondary outcomes
Percentage of patients that need a postoperative blood transfusion
Time frame: During the first postoperative week
Percentage of patients with surgical wound infection
Time frame: During the first postoperative month
Percentage of patients with surgical wound dehiscence
Time frame: During the first postoperative month
Percentage of patients with re-intervention by wound complications
Time frame: During the first postoperative month
Incidence of deep venous thrombosis
Time frame: During the first postoperative week
Pain of surgical wound
Time frame: During the first postoperative week
Units of blood transfusion
Time frame: During the first postoperative week
hospital length stay
Time frame: Days
Mortality
Time frame: During the first postoperative month
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 28 Aug 2013.
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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.
Martinez Zapata, Mª José study director
Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
Aguilera Roig, Xavier principal investigator
Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
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, Fibrin glue and Habitual haemostasis in people with Knee Arthropathy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 2 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 28 Aug 2013. 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?
Postoperative blood loss (mL) (time frame: During the first 48h after the surgical intervention). 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 28 Aug 2013.