Tranexamic AcidTXANCT01980355
TXA Study in Major Oncologic Surgery
A study testing Tranexamic Acid in people with Tranexamic Acid and Cancer, run by Corewell Health West at 1 site in United States.
Trial summary
Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tranexamic Acid, Cancer, Major Surgery
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2012to 29 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects undergoing major oncologic surgery for standard of care purposes (to include, but not limited to: liver resections, radical cholecystectomy, pancreaticoduodenectomy (Whipple procedure), esophagectomy, gastrectomy, colectomy, debulking with hyperthermic intraperitoneal chemotherapy, prostatectomies, nephrectomies and partial nephrectomies)
- Male or female > 18 years of age
- Subject agrees to participate in this study and provides informed consent
Who cannot join
- Subjects with a history of hypercoagulopathy, deep vein thrombosis or pulmonary embolism
- Subjects that are on therapeutic anticoagulation or therapeutic antiplatelet medications at the time of surgery other than Aspirin
- Subjects with a history of TIA or stroke
- Subjects with a history of atrial fibrillation
- Subjects with a known thrombus
- Baseline creatinine level greater than 2.83 mg/dL
Show all 13Show fewer
- Subjects with known hypersensitivity to tranexamic acid
- Adults unable to provide informed consent
- Children
- Pregnant women
- Prisoners
- Non-English speaking subjects
- Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Hospitals
Grand Rapids, Michigan, 49506
About this study
Official title: The Effect of Tranexamic Acid on Blood Loss and Transfusion Rates in Major Oncologic Surgery
Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your surgical hospital stay.
In this study, you will receive either the drug tranexamic acid or a placebo. The placebo looks like the tranexamic acid, but does not have any active ingredient in it. The treatment you get will be chosen by chance, like flipping a coin. You will have equal chance of being given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the placebo are considered research.
Read the detailed description
Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment you are getting.
You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.
Information from your medical record related to your surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with your study number instead of your name. Additionally, if you return to the hospital within 90 days after you went home from the hospital, information about that hospital visit(s) will also be collected from your medical record.
- Conditions
- Tranexamic Acid, Cancer, Major Surgery
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- cancer, surgery, oncology, major, surgical oncology, tranexamic acid
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Placebo given over 15 minutes into the vein once prior to surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Required Transfusion
To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery
Measured: From time of surgery to 90 days post hospital discharge
Secondary outcomes (1)
Estimated Blood Loss
Surgical blood loss estimation
Measured: From time of surgery to 90 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start12 Jun 2012
- Primary completion1 Dec 2017
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tranexamic AcidStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald P. Wright, Corewell Health West
- Investigators
- Gerald P Wright, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980355
- Sponsor's protocol ID
- 2012-133
- Acronym
- TXA
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2013
- Last updated
- 7 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vermylen J, Verhaegen-Declercq ML, Verstraete M, Fierens F. A double blind study of the effect of tranexamic acid in essential menorrhagia. Thromb Diath Haemorrh. 1968 Dec 31;20(3):583-7. No abstract available.
PubMed 5710474Casati V, Gerli C, Franco A, Torri G, D'Angelo A, Benussi S, Alfieri O. Tranexamic acid in off-pump coronary surgery: a preliminary, randomized, double-blind, placebo-controlled study. Ann Thorac Surg. 2001 Aug;72(2):470-5. doi: 10.1016/s0003-4975(01)02802-8.
PubMed 11515884Massicotte L, Denault AY, Beaulieu D, Thibeault L, Hevesi Z, Roy A. Aprotinin versus tranexamic acid during liver transplantation: impact on blood product requirements and survival. Transplantation. 2011 Jun 15;91(11):1273-8. doi: 10.1097/TP.0b013e31821ab9f8.
PubMed 21617589Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.
PubMed 22012809CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: a critical review of the literature. J Trauma. 2011 Jul;71(1 Suppl):S9-14. doi: 10.1097/TA.0b013e31822114af.
PubMed 21795884Wu CC, Ho WM, Cheng SB, Yeh DC, Wen MC, Liu TJ, P'eng FK. Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a "blood transfusion"-free hepatectomy. Ann Surg. 2006 Feb;243(2):173-80. doi: 10.1097/01.sla.0000197561.70972.73.
PubMed 16432349Kalavrouziotis D, Voisine P, Mohammadi S, Dionne S, Dagenais F. High-dose tranexamic acid is an independent predictor of early seizure after cardiopulmonary bypass. Ann Thorac Surg. 2012 Jan;93(1):148-54. doi: 10.1016/j.athoracsur.2011.07.085. Epub 2011 Nov 4.
PubMed 22054656Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2.
PubMed 17943760
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid on Blood Loss and Transfusion Rates in Major Oncologic Surgery
- ClinicalTrials.gov ID
- NCT01980355
- Acronym / sponsor ID
- TXA / 2012-133
- Conditions
- Tranexamic Acid, Cancer, Major Surgery
- Keywords
- cancer, surgery, oncology, major, surgical oncology, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 12 Jun 2012 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your surgical hospital stay.
In this study, you will receive either the drug tranexamic acid or a placebo. The placebo looks like the tranexamic acid, but does not have any active ingredient in it. The treatment you get will be chosen by chance, like flipping a coin. You will have equal chance of being given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the placebo are considered research.
Detailed description
Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment you are getting.
You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.
Information from your medical record related to your surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with your study number instead of your name. Additionally, if you return to the hospital within 90 days after you went home from the hospital, information about that hospital visit(s) will also be collected from your medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic Acid1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo given over 15 minutes into the vein once prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects undergoing major oncologic surgery for standard of care purposes (to include, but not limited to: liver resections, radical cholecystectomy, pancreaticoduodenectomy (Whipple procedure), esophagectomy, gastrectomy, colectomy, debulking with hyperthermic intraperitoneal chemotherapy, prostatectomies, nephrectomies and partial nephrectomies)
- Male or female > 18 years of age
- Subject agrees to participate in this study and provides informed consent
Key exclusion criteria (13 listed)
- Subjects with a history of hypercoagulopathy, deep vein thrombosis or pulmonary embolism
- Subjects that are on therapeutic anticoagulation or therapeutic antiplatelet medications at the time of surgery other than Aspirin
- Subjects with a history of TIA or stroke
- Subjects with a history of atrial fibrillation
- Subjects with a known thrombus
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 |
|---|---|---|
| Tranexamic Acid | Drug | Tranexamic Acid |
| Placebo | Other | Placebo |
Primary outcome
Number of Participants Who Required Transfusion
Time frame: From time of surgery to 90 days post hospital discharge
To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery
1 secondary outcome
Estimated Blood Loss
Time frame: From time of surgery to 90 days post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 5710474Vermylen J, Verhaegen-Declercq ML, Verstraete M, Fierens F. A double blind study of the effect of tranexamic acid in essential menorrhagia. Thromb Diath Haemorrh. 1968 Dec 31;20(3):583-7. No abstract available.
- Background: PubMed 11515884Casati V, Gerli C, Franco A, Torri G, D'Angelo A, Benussi S, Alfieri O. Tranexamic acid in off-pump coronary surgery: a preliminary, randomized, double-blind, placebo-controlled study. Ann Thorac Surg. 2001 Aug;72(2):470-5. doi: 10.1016/s0003-4975(01)02802-8.
- Background: PubMed 21617589Massicotte L, Denault AY, Beaulieu D, Thibeault L, Hevesi Z, Roy A. Aprotinin versus tranexamic acid during liver transplantation: impact on blood product requirements and survival. Transplantation. 2011 Jun 15;91(11):1273-8. doi: 10.1097/TP.0b013e31821ab9f8.
- Background: PubMed 22012809Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.
- Background: PubMed 20554319CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Background: PubMed 21795884Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: a critical review of the literature. J Trauma. 2011 Jul;71(1 Suppl):S9-14. doi: 10.1097/TA.0b013e31822114af.
- Background: PubMed 16432349Wu CC, Ho WM, Cheng SB, Yeh DC, Wen MC, Liu TJ, P'eng FK. Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a "blood transfusion"-free hepatectomy. Ann Surg. 2006 Feb;243(2):173-80. doi: 10.1097/01.sla.0000197561.70972.73.
- Background: PubMed 22054656Kalavrouziotis D, Voisine P, Mohammadi S, Dionne S, Dagenais F. High-dose tranexamic acid is an independent predictor of early seizure after cardiopulmonary bypass. Ann Thorac Surg. 2012 Jan;93(1):148-54. doi: 10.1016/j.athoracsur.2011.07.085. Epub 2011 Nov 4.
- Background: PubMed 17943760Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2.
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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.
Gerald P Wright, MD principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Tranexamic Acid and Cancer, run by Corewell Health West at 1 site in United States.
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 3 inclusion and 13 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 7 Aug 2023. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Required Transfusion (time frame: From time of surgery to 90 days post hospital discharge). 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 NCT01980355, which also lists 9 linked publications.
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 7 Aug 2023.