CancerPhase 3NCT01651182
Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection
A Phase 3 study testing No tranexamic acid and Tranexamic Acid in people with Cancer and Tumour, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- No tranexamic acid and Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Feb 2015
- 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
- Patient undergoing anticipated open or laparoscopic major liver resection (> 2 hepatic segments), as assessed by the operating surgeon
- Age ≥ 18 years.
Who cannot join
- Previously enrolled in this study
- Platelet count less than 100,000/mm3
- Severe anemia (hemoglobin levels less than 90 g/l)
- Documented arterial or venous thrombosis at screening or in past three months
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
- Hepatectomy associated with planned vascular or biliary reconstruction
Show all 14Show fewer
- Known disseminated intravascular coagulation
- Severe renal insufficiency (CrCl<30)
- History of seizure disorder
- Pregnant or lactating
- Hypersensitivity to tranexamic acid or any of the ingredients
- Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction)
- Receipt of chemotherapy within 4 weeks of scheduled operation
- Patients undergoing resection for living donor liver transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection
Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver resection are at risk of severe perioperative blood loss and may also benefit from perioperative TXA administration.
This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic properties of two well studied dosing regimens of TXA will provide guidance in determining the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling evidence of the effectiveness of TXA comes from the large multicentred, multi-national CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.
Although TXA is not currently approved for use in patients undergoing major liver resection, Health Canada has allowed the use of tranexamic acid for use in this research study.
- Being tested
- No tranexamic acid, Tranexamic Acid
- Keywords
- Blood transfusion, Blood loss, Postoperative complications, Outcome
- Medical subject headings
- Neoplasms, Hemorrhage, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No tranexamic acidDrug
Control
Tranexamic AcidDrug
Also called Cyklokapron
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | No tranexamic acid Receives: Drug: No tranexamic acid |
| Dose 1 | Experimental | 1 g bolus + 1 g infusion from induction over 8 hours Receives: Drug: Tranexamic Acid |
| Dose 2 | Experimental | 1 g bolus + 10 mg/kg/hr from induction until end of surgery Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of blood transfusion(s)
Measured: 7 days
Secondary outcomes (4)
Fibrinolytic Markers
Measured: Baseline - Postoperative Day 0-7
Pharmacokinetic Study
Measured: Baseline - Postoperative Day 0-7
Post-operative incidence of symptomatic venous thromboembolic event
Measured: 30 days
Other post-operative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Paul Karanicolas, MD PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651182
- Sponsor's protocol ID
- TXA Liver - PK
- Status last verified
- Sep 2015
- First submitted
- 24 Jul 2012
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Karanicolas PJ, Lin Y, Tarshis J, Law CH, Coburn NG, Hallet J, Nascimento B, Pawliszyn J, McCluskey SA. Major liver resection, systemic fibrinolytic activity, and the impact of tranexamic acid. HPB (Oxford). 2016 Dec;18(12):991-999. doi: 10.1016/j.hpb.2016.09.005. Epub 2016 Oct 18.
PubMed 27765582
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection
- ClinicalTrials.gov ID
- NCT01651182
- Acronym / sponsor ID
- TXA Liver - PK
- Keywords
- Blood transfusion, Blood loss, Postoperative complications, Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Toronto, University Health Network, Toronto
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Jul 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.
Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver resection are at risk of severe perioperative blood loss and may also benefit from perioperative TXA administration.
This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic properties of two well studied dosing regimens of TXA will provide guidance in determining the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling evidence of the effectiveness of TXA comes from the large multicentred, multi-national CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.
Although TXA is not currently approved for use in patients undergoing major liver resection, Health Canada has allowed the use of tranexamic acid for use in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Drug: No tranexamic acidNo tranexamic acid |
| Dose 1 | Experimental | Drug: Tranexamic Acid1 g bolus + 1 g infusion from induction over 8 hours |
| Dose 2 | Experimental | Drug: Tranexamic Acid1 g bolus + 10 mg/kg/hr from induction until end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing anticipated open or laparoscopic major liver resection (> 2 hepatic segments), as assessed by the operating surgeon
- Age ≥ 18 years.
Key exclusion criteria (14 listed)
- Previously enrolled in this study
- Platelet count less than 100,000/mm3
- Severe anemia (hemoglobin levels less than 90 g/l)
- Documented arterial or venous thrombosis at screening or in past three months
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
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 |
|---|---|---|
| No tranexamic acidControl | Drug | Standard Care |
| Tranexamic AcidAlso: Cyklokapron | Drug | Dose 1, Dose 2 |
Primary outcome
Receipt of blood transfusion(s)
Time frame: 7 days
4 secondary outcomes
Fibrinolytic Markers
Time frame: Baseline - Postoperative Day 0-7
Pharmacokinetic Study
Time frame: Baseline - Postoperative Day 0-7
Post-operative incidence of symptomatic venous thromboembolic event
Time frame: 30 days
Other post-operative complications
Time frame: 30 days
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 18 Sep 2015.
- Derived from this study: PubMed 27765582Karanicolas PJ, Lin Y, Tarshis J, Law CH, Coburn NG, Hallet J, Nascimento B, Pawliszyn J, McCluskey SA. Major liver resection, systemic fibrinolytic activity, and the impact of tranexamic acid. HPB (Oxford). 2016 Dec;18(12):991-999. doi: 10.1016/j.hpb.2016.09.005. Epub 2016 Oct 18.
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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.
Paul Karanicolas, MD PhD principal investigator
Sunnybrook Health Sciences Centre
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 No tranexamic acid and Tranexamic Acid in people with Cancer and Tumour, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 14 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 18 Sep 2015. 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 Canada. 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 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?
Receipt of blood transfusion(s) (time frame: 7 days). 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 NCT01651182, 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 18 Sep 2015.