The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial (HeLiX)
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| ClinicalTrials.gov Identifier: NCT02261415 |
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Recruitment Status :
Recruiting
First Posted : October 10, 2014
Last Update Posted : September 26, 2018
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Sponsor:
Sunnybrook Health Sciences Centre
Collaborator:
HepatoPancreaticoBiliary (HPB) Concept Team
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
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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
| 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
Drug Information available for:
Tranexamic acid
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tranexamic acid (TXA)
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
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Drug: Tranexamic acid (TXA)
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
Other Name: Cyklokapron |
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Placebo Comparator: Normal saline (0.9% sodium chloride)
1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
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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 :
- 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 :
- 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)
- 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
- Number of packed red blood cells (PRBC) units transfused [ Time Frame: 7 days ]Number of packed red blood cells (PRBC) units transfused (POD0 - POD7)
- 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)
- 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
- 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.
- 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.
- 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.
- 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.
- Perioperative mortality [ Time Frame: 7 days ]Perioperative mortality will be recorded between POD0 and POD7
- 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).
Information from the National Library of Medicine
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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
| 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
| 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
| Principal Investigator: | Paul Karanicolas, MD PhD | Sunnybrook Health Sciences Centre |
| 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:
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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 |