Blood Loss, SurgicalPhase 4NCT02335359
Tranexamic Acid in Major Vascular Surgery
A Phase 4 study testing tranexamic acid diluted in 100 ml of saline solution (loading dose) and tranexamic acid undiluted (continous infusion) in people with Blood Loss, Surgical, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- tranexamic acid diluted in 100 ml of saline solution (loading dose) and tranexamic acid undiluted (continous infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2015to 30 Oct 2018
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50
- Able to give written informed consent
- Undergoing open abdominal aortic aneurysm repair
Who cannot join
- Patients participating in a pharmaceutical clinical trial in the last 3 months
- Urgent/emergent surgery
- Allergy/intolerance to tranexamic acid
- History of seizures
- Acute Venous or Arterial Thrombosis
- Fibrinolytic conditions due to consumption coagulopathy
Show all 9Show fewer
- Disseminated intravascular coagulation
- Haematuria
- Visual disturbances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.
The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair
- Conditions
- Blood Loss, Surgical
- Being tested
- tranexamic acid diluted in 100 ml of saline solution (loading dose), tranexamic acid undiluted (continous infusion), Placebo
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acid diluted in 100 ml of saline solution (loading dose)Drug
tranexamic acid undiluted (continous infusion)Drug
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure. Receives: Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose); Drug: tranexamic acid undiluted (continous infusion) |
| Placebo | Placebo comparator | Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss (milliliters)
Measured: intraoperative (from skin incision to skin closure)
Secondary outcomes (3)
Number of packed blood red cells transfused
Measured: hospital stay (an average of one week)
Occurrence of thromboembolic events (of any nature)
Measured: 28-days and one year after surgery
Mortality
Measured: 28-days and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study start4 Mar 2015
- Primary completion30 Oct 2017
- Study completion30 Oct 2018
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 Loss, SurgicalStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Pasin, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335359
- Sponsor's protocol ID
- Tranex-AAA/34/OSR
- Status last verified
- May 2019
- First submitted
- 7 Jan 2015
- Last updated
- 14 May 2019
- Results posted
- No
Publications
Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10.
PubMed 31607387
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02335359
- Acronym / sponsor ID
- Tranex-AAA/34/OSR
- Conditions
- Blood Loss, Surgical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 4 Mar 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 9 Jan 2015 (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 purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose), Drug: tranexamic acid undiluted (continous infusion)A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure. |
| Placebo | Placebo comparator | Drug: PlaceboSaline |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 50
- Able to give written informed consent
- Undergoing open abdominal aortic aneurysm repair
Key exclusion criteria (9 listed)
- Patients participating in a pharmaceutical clinical trial in the last 3 months
- Urgent/emergent surgery
- Allergy/intolerance to tranexamic acid
- History of seizures
- Acute Venous or Arterial Thrombosis
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 diluted in 100 ml of saline solution (loading dose) | Drug | Tranexamic Acid |
| tranexamic acid undiluted (continous infusion) | Drug | Tranexamic Acid |
| PlaceboSaline | Drug | Placebo |
Primary outcome
Blood loss (milliliters)
Time frame: intraoperative (from skin incision to skin closure)
3 secondary outcomes
Number of packed blood red cells transfused
Time frame: hospital stay (an average of one week)
Occurrence of thromboembolic events (of any nature)
Time frame: 28-days and one year after surgery
Mortality
Time frame: 28-days and one year 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 14 May 2019.
- Derived from this study: PubMed 31607387Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10.
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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.
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 Phase 4 study testing tranexamic acid diluted in 100 ml of saline solution (loading dose) and tranexamic acid undiluted (continous infusion) in people with Blood Loss, Surgical, run by IRCCS San Raffaele at 1 site in Italy.
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 9 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 May 2019. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (milliliters) (time frame: intraoperative (from skin incision to skin closure)). 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 NCT02335359, 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 14 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.