Blood Loss, SurgicalPhase 3NCT00657384
Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy
A Phase 3 study testing acid tranexamic and Nacl 0.9% in people with Blood Loss, Surgical, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- acid tranexamic and Nacl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Aug 2008to Nov 2013
- 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
- Signature of the consent form
- Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)
Who cannot join
- Absence of signature of the consent form
- Patient with cirrhosis
- Minor hepatectomy (< 3 hepatic segments)
- Hepatectomy associated with vascular resection
- Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection
- Pregnant or lactation
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Amiens, Hôpital Nord
Amiens, 80054
Chirurgie digestive et transplantation, Hôpital de Besançon
Besançon
CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)
Bordeaux, 33000
Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg
Strasbourg, 67098
About this study
Official title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study
Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).
- Conditions
- Blood Loss, Surgical
- Being tested
- acid tranexamic, Nacl 0.9%
- Keywords
- Specify the primary condition or disease being studied Major Hepatectomy
- 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.
acid tranexamicDrug
10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention.
Nacl 0.9%Drug
10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention
| Study group | Role | What they receive |
|---|---|---|
| acid tranexamic | Experimental | acid tranexamic Receives: Drug: acid tranexamic |
| 2 | Placebo comparator | Nacl 0.9% Receives: Drug: Nacl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).
Measured: at day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study start20 Aug 2008
- Primary completion20 Aug 2013
- Study completionNov 2013
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Pessaux, Principal investigator, CHU strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657384
- Sponsor's protocol ID
- 3959
- Status last verified
- Feb 2021
- First submitted
- 8 Apr 2008
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study
- ClinicalTrials.gov ID
- NCT00657384
- Acronym / sponsor ID
- 3959
- Conditions
- Blood Loss, Surgical
- Keywords
- Specify the primary condition or disease being studied Major Hepatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Aug 2008 (actual)
- Primary completion
- 20 Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Apr 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.
Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acid tranexamic | Experimental | Drug: acid tranexamicacid tranexamic |
| 2 | Placebo comparator | Drug: Nacl 0.9%Nacl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signature of the consent form
- Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)
Key exclusion criteria (6 listed)
- Absence of signature of the consent form
- Patient with cirrhosis
- Minor hepatectomy (< 3 hepatic segments)
- Hepatectomy associated with vascular resection
- Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection
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 |
|---|---|---|
| acid tranexamic10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention. | Drug | acid tranexamic |
| Nacl 0.9%10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention | Drug | 2 |
Primary outcome
The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).
Time frame: at day 5
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
Related trials for Blood Loss, Surgical
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
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.
Patrick Pessaux principal investigator
CHU strasbourg
4 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 acid tranexamic and Nacl 0.9% in people with Blood Loss, Surgical, run by University Hospital, Strasbourg, France at 4 sites in France.
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: stopped early, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 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 was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
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?
The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%). (time frame: at day 5). 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 1 Mar 2021.