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The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial (HeLiX)

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ClinicalTrials.gov Identifier: NCT02261415
Recruitment Status : Recruiting
First Posted : October 10, 2014
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
HepatoPancreaticoBiliary (HPB) Concept Team
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:
This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. The sample size for this study is 1230 participants.Participants enrolled in the prior Vanguard study will proceed directly into the RCT.

Condition or disease Intervention/treatment Phase
Cancer Tumour Surgery Drug: Tranexamic acid (TXA) Drug: Normal saline Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial: Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: A Randomized Controlled Trial
Study Start Date : November 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid (TXA)
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
Drug: Tranexamic acid (TXA)
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
Other Name: Cyklokapron

Placebo Comparator: Normal saline (0.9% sodium chloride)
1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
Drug: Normal saline
1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
Other Name: 0.9% sodium chloride




Primary Outcome Measures :
  1. Receipt of blood transfusion (% transfused): 7 days [ Time Frame: 7 days ]
    Receipt of one or more RBC transfusions between Day 0 and Day 7


Secondary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: 7 days ]
    Intraoperative blood loss will be assessed by adding the net weight of sponges and fluid suction (minus irrigation and intraoperative bile or other fluids in suction/sponge)

  2. Total blood loss [ Time Frame: 7 days ]
    Total blood loss (postoperative day (POD)0 - POD7) will be assessed by Gross' formula, which uses the maximum postoperative decrease in the level of hemoglobin adjusted for the weight and height of the patient

  3. Number of packed red blood cells (PRBC) units transfused [ Time Frame: 7 days ]
    Number of packed red blood cells (PRBC) units transfused (POD0 - POD7)

  4. Postoperative incidence of symptomatic venous thromboembolic event [ Time Frame: 90 days ]
    Postoperative incidence of symptomatic venous thromboembolic event confirmed with either computed tomography (CT) angiogram (for pulmonary embolism) or venous Doppler ultrasound (for deep venous thrombosis) (within 90 days of surgery)

  5. Postoperative complications assessed using Clavien-Dindo Grading System [ Time Frame: 90 days ]
    Postoperative complications (within 90 days of surgery) will be determined using the Clavien-Dindo classification

  6. Recurrence Free Survival (within 5 years of surgery) [ Time Frame: 60 months ]
    Disease recurrence is defined as the clinical presence of cancer that has either been confirmed by biopsy, has had treatment initiated, or is documented in the treating physician's notes. Five year disease recurrence from day of surgery will be evaluated approximately every 6 months until 5 years via medical record review.

  7. Overall Survival (within 5 years of surgery) [ Time Frame: 60 months ]
    Overall survival is defined as the time from date of surgery to death from any cause. It will be determined by review of patient medical record every 6 months until 5 years post-surgery.

  8. Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: Baseline, 30 days, 90 days ]
    QOL will be determined by administering the EORTC QLQ-C30 at baseline, 30 and 90 days following surgery.

  9. Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Liver Module (LM)C21 Questionnaire [ Time Frame: Baseline, 30 days, 90 days ]
    QOL will be determined by administering QLQ-LMC21 at baseline, 30 and 90 days following surgery.

  10. Perioperative mortality [ Time Frame: 7 days ]
    Perioperative mortality will be recorded between POD0 and POD7

  11. Compare the cost of tranexamic acid (TXA) versus placebo on perioperative blood transfusion in patients undergoing liver resection [ Time Frame: 90 days ]
    Economic analysis will assess impact of TXA incorporation on health care resources and strategies for systematic utilization of TXA. The analysis will be using data collected in the randomized controlled trial from a societal perspective.The output of the economic analysis is the incremental cost of TXA compared to placebo (control group).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient scheduled for open or laparoscopic liver surgery
  • Age ≥18 years

Exclusion Criteria:

  • Severe anemia (hemoglobin (Hgb) levels <90 g/l)
  • Documented arterial or venous thrombosis at screening or in past three months (not including therapeutic portal vein embolization)
  • Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
  • Known disseminated intravascular coagulation
  • Severe renal insufficiency (creatinine clearance (CrCl) <30 ml/min)
  • History of seizure disorder
  • Pregnant or lactating (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)
  • Acquired disturbance of colour vision
  • Hypersensitivity to TXA 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)
  • Previously enrolled in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261415


Contacts
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Contact: Danusha Nandamalavan 416-864-6060 ext 77038 nandamalavad@smh.ca
Contact: Rachel Roke, BSc (Hons) 416-480-6100 ext 85391 rachel.roke@sunnybrook.ca

Locations
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Canada, Alberta
Foothills Hospital Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Elijah Dixon    403-521-3323    elijah.dixon@calgaryhealthregion.ca   
Contact: Susan Isherwood    403-944-3649    susan.isherwood@albertahealthservices.ca   
Principal Investigator: Elijah Dixon         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2YR
Contact: Geoff Porter    902-473-6499    geoff.porter@cdha.nshealth.ca   
Contact: Margaret Jorgensen    902-473-7290    margaret.jorgensen@ccns.nshealth.ca   
Principal Investigator: Geoff Porter         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 8E7
Contact: Leyo Ruo    905-521-2100    ruol@mcmaster.ca   
Contact: Elisabeth Lo    905-521-2100 ext 43921    loe3@mcmaster.ca   
Principal Investigator: Leyo Ruo         
Kingston General Health Research Insititute Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Sulaiman Nanji    613-549-6666    Sulaiman.Nanji@kingstonhsc.ca   
Contact: Angel Zhou    613-549-6666 ext 6685    angel.zhou@kingstonhsc.ca   
Principal Investigator: Sulaiman Nanji         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Anton Skaro    (519)663-2904    Anton.Skaro@lhsc.on.ca   
Contact: Karen Dunn    519-646-6000 ext 64825    Karen.Dunn@lhsc.on.ca   
Principal Investigator: Anton Skaro         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Paul Karanicolas, MD PhD    416-480-4774    paul.karanicolas@sunnybrook.ca   
Contact: Rachel Roke, BSc (Hons)    416-480-6100 ext 85391    rachel.roke@sunnybrook.ca   
Principal Investigator: Paul Karanicolas, MD PhD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Alice Wei    416-340-4232    alice.wei@uhn.ca   
Contact: Dorian Facey    416-340-4800    Dorian.Facey@uhn.ca   
Principal Investigator: Alice Wei         
St. Joseph's Health Centre Recruiting
Toronto, Ontario, Canada, M6R 1B5
Contact: Melanie Tsang    (416) 530-6818    MTsang@stjoestoronto.ca   
Contact: Kanthi Kavikondala    (416) 530-6818    KKavikondala@stjoestoronto.ca   
Principal Investigator: Melanie Tsang         
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Prosanto Chaudhury    519-934-1934 ext 31951    prosanto.chaudhury@mcgill.ca   
Contact: Cristina Al-Ali    519-934-1934 ext 36569    Cristina.Al-Ali@MUHC.MCGILL.CA   
Principal Investigator: Prosanto Chaudhury         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
HepatoPancreaticoBiliary (HPB) Concept Team
Investigators
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Principal Investigator: Paul Karanicolas, MD PhD Sunnybrook Health Sciences Centre

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02261415     History of Changes
Other Study ID Numbers: 244-2014
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sunnybrook Health Sciences Centre:
blood transfusion
blood loss
feasibility
outcome
liver resection
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants