NCT01651182

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3 cancer

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 24, 2012

Last Update Submit

September 17, 2015

Conditions

CancerTumourSurgery

Keywords

Blood transfusionBlood lossPostoperative complicationsOutcome

Outcome Measures

Primary Outcomes (1)

  • Receipt of blood transfusion(s)

    7 days

Secondary Outcomes (4)

  • Fibrinolytic Markers

    Baseline - Postoperative Day 0-7

  • Pharmacokinetic Study

    Baseline - Postoperative Day 0-7

  • Post-operative incidence of symptomatic venous thromboembolic event

    30 days

  • Other post-operative complications

    30 days

Study Arms (3)

Standard Care

PLACEBO COMPARATOR

No tranexamic acid

Drug: No tranexamic acid

Dose 1

EXPERIMENTAL

1 g bolus + 1 g infusion from induction over 8 hours

Drug: Tranexamic Acid

Dose 2

EXPERIMENTAL

1 g bolus + 10 mg/kg/hr from induction until end of surgery

Drug: Tranexamic Acid

Interventions

No tranexamic acidDRUG

Control

Standard Care
Tranexamic AcidDRUG
Also known as: Cyklokapron
Dose 1Dose 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing anticipated open or laparoscopic major liver resection (\> 2 hepatic segments), as assessed by the operating surgeon
  • Age ≥ 18 years.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27765582DERIVED

MeSH Terms

Conditions

NeoplasmsHemorrhagePostoperative Complications

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Paul Karanicolas, MD PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

CA(1)