BleedingPhase 4TRANEX-URONCT00670345

Tranexamic Acid in Urologic Surgery

A Phase 4 study testing Tranexamic Acid in people with Bleeding and Prostatectomy, run by Università Vita-Salute San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Bleeding, Prostatectomy
What is being tested?: Tranexamic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: Not given
Where: 1 siteItaly
Study dates: Apr 2008to Jun 2010
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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients
Patients undergoing open radical prostatectomy

Who cannot join

Age < 18 years
Patients with drug eluting stent with a double antiplatelet therapy
Atrial fibrillation
Thrombophilic diathesis
Allergy to tranexamic acid

Trial locations and contacts

1 site in 1 country.

Italy1 site

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milan, 20132

Other trials in Italy

About this study

Official title: Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.

This prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure.

200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.

Patients belonging to the control group will receive the same volume of saline infusions.

Conditions: Bleeding, Prostatectomy
Being tested: Tranexamic Acid, Placebo
Keywords: tranexamic acid, prostatectomy, surgery
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 TRANEX, UGUROL
Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.
PlaceboDrug
Patients belonging to the control group will receive the same volume of saline infusions.

Study groups in NCT00670345
Study group	Role	What they receive
1	Experimental	Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion. Receives: Drug: Tranexamic Acid
2	Placebo comparator	Patients belonging to the control group will receive the same volume of saline infusions. Receives: Drug: Placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jun 2010

First posted1 May 2008 (estimated)
Study startApr 2008
Primary completionMay 2010
Study completionJun 2010

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 BleedingStudies 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

IDs, dates and publications

ClinicalTrials.gov ID: NCT00670345
Sponsor's protocol ID: GO/URC/ER/mm 139/DG
Acronym: TRANEX-URO
Status last verified: Jul 2010
First submitted: 29 Apr 2008
Last updated: 7 Apr 2014
Results posted: No

Publications

Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.
PubMed 22012809

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.
ClinicalTrials.gov ID: NCT00670345
Acronym / sponsor ID: TRANEX-URO / GO/URC/ER/mm 139/DG
Conditions: Bleeding, Prostatectomy
Keywords: tranexamic acid, prostatectomy, surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Università Vita-Salute San RaffaeleUniversity, hospital or other
Study start: Apr 2008
Primary completion: May 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 1 May 2008 (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.

Patients belonging to the control group will receive the same volume of saline infusions.

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
1	Experimental	Drug: Tranexamic AcidPatients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.
2	Placebo comparator	Drug: PlaceboPatients belonging to the control group will receive the same volume of saline infusions.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult patients
Patients undergoing open radical prostatectomy

Key exclusion criteria (5 listed)

Age < 18 years
Patients with drug eluting stent with a double antiplatelet therapy
Atrial fibrillation
Thrombophilic diathesis
Allergy to tranexamic acid

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: TRANEX, UGUROLPatients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.	Drug	1
PlaceboPatients belonging to the control group will receive the same volume of saline infusions.	Drug	2

Primary outcome

Not reported in the source record.

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 7 Apr 2014.
Results publication: PubMed 22012809Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.

Related trials for Bleeding

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RecruitingPhase 3
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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.

Giovanni Landoni, MD study director

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Antonella Crescenti, MD principal investigator

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

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 in people with Bleeding and Prostatectomy, run by Università Vita-Salute 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 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 7 Apr 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 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670345, 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 7 Apr 2014.