Inhaled Tranexamic Acid for Bleeding in Cancer Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Anti-epileptics, Anti-fibrinolytics
Disqualifiers: DNR, 100% FIO2, COVID-19, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
This is a drug study that will examine if inhaled tranexamic acid can improve mortality in patients with cancer-related pulmonary hemorrhage and respiratory failure as compared to usual care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-fibrinolytic therapy (medications that prevent blood clots from breaking down).
What data supports the effectiveness of the drug Tranexamic Acid for bleeding in cancer patients?
Research suggests that inhaled tranexamic acid can quickly control bleeding in patients with non-massive hemoptysis (coughing up blood), which is a common issue in cancer patients with respiratory involvement. Additionally, tranexamic acid is known to reduce blood loss in surgical settings, indicating its potential to manage bleeding effectively.12345
Is inhaled tranexamic acid safe for cancer patients?
Tranexamic acid (TXA) has been studied for safety in various conditions, including cancer patients undergoing chemotherapy or surgery. In a study with cancer patients, TXA did not significantly increase serious bleeding or thrombotic events (blood clots), and common side effects were similar to those in the placebo group, including diarrhea, fatigue, and nausea.12367
Eligibility Criteria
This trial is for adults over 18 with blood cancers who are on mechanical ventilation due to lung bleeding. They must be expected to live more than 48 hours, not have a severe brain bleed, no DNR orders, and not be pregnant or have COVID-19. People with recent blood clots, known allergies to tranexamic acid, color vision issues, seizures under treatment, or prior use of inhaled tranexamic acid can't join.Inclusion Criteria
Evidence of diffuse alveolar hemorrhage by bronchoscopic examination
Persistently bloody secretions upon endotracheal tube suctioning
I have signed the consent form, or my legal representative has.
See 4 more
Exclusion Criteria
You have a nose or mouth that is bleeding and causing bloody secretions.
I am currently taking medication for epilepsy.
I am currently infected with COVID-19.
See 11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive inhaled tranexamic acid or usual care for pulmonary hemorrhage
3-5 days
Daily administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
28 days
Extended Follow-up
Monitoring of secondary outcomes such as ICU and hospital mortality rate, ventilator days, and length of stay
100 days
Treatment Details
Interventions
- Tranexamic Acid (Anti-fibrinolytic agent)
- Usual Care (Other)
Trial OverviewThe study tests if breathing in the drug tranexamic acid helps reduce death rates in cancer patients with lung bleeding compared to standard treatments. Patients will either receive the usual care or the added inhalation therapy and their survival outcomes will be compared.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Group B: Usual CareExperimental Treatment1 Intervention
usual care
Group II: Group A: Inhaled tranexamic acidExperimental Treatment1 Intervention
will receive 500 mg/5ml nebulized tranexamic acid every 8 hours for at least 3 days, and up to 5 days
Tranexamic Acid is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇪🇺 Approved in European Union as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
- Hereditary angioedema
🇨🇦 Approved in Canada as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇯🇵 Approved in Japan as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇦🇺 Approved in Australia as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Nebulized Tranexamic Acid as a Noninvasive Therapy for Cancer-Related Hemoptysis. [2015]Many patients with cancer involving the respiratory system suffer from the frequent recurrence of significant, submassive hemoptysis, which may result in invasive procedures, hospital stays, and a reduction in quality of life. Currently, there are no widely accepted noninvasive therapeutic options. Few case studies have looked at the benefit of tranexamic acid (TXA) as a noninvasive therapy in the treatment of hemoptysis.
Does tranexamic acid reduce risk of mortality on patients with hemoptysis?: A protocol for systematic review and meta-analysis. [2023]Although tranexamic acid (TXA), a readily accessible antifibrinolytic agent, is widely adopted in hemorrhage scenarios, its role on mortality in patients with hemoptysis remains uncertain. New evidence is yet to be generated to evaluate the risk of mortality after using TXA in patients with hemoptysis.
Tranexamic acid in patients with current or former cancer undergoing hip and knee arthroplasty. [2021]While tranexamic acid (TXA) is an excellent mechanism to reduce blood loss in arthroplasty, its safety in cancer patients-who could potentially benefit the most from blood conservation-is unknown.
BET 1: Does inhaled tranexamic acid reduce morbidity in adults with haemoptysis? [2020]A short cut review was carried out to establish whether inhaled tranexamic acid is more effective than placebo at controlling bleeding in patients with haemoptysis. Thirty-four papers were found using the reported searches, of which one presented the best available evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of this paper is tabulated. It is concluded that in patients with non-massive haemoptysis, management with nebulised TXA leads to fast resolution.
Blood loss and perioperative transfusions related to surgery for spinal tumors. Relevance of tranexamic acid. [2020]Tranexamic acid (TXA) has been shown to reduce bleeding. Patients with spinal tumors are fragile and acute anemia may be harmful. Tumor excision surgery is reputed to be hemorrhagic and treatment may increase thromboembolic complications. The aim of this study was to compare blood loss with or without perioperative TXA injection. The transfusion-related and postoperative complications were documents.
Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial. [2023]Evidence of the effectiveness of prophylactic use of tranexamic acid (TXA) in thrombocytopenia is lacking. To determine whether TXA safely reduces bleeding incidence in patients undergoing treatment for hematologic malignancies, a randomized, double-blind clinical trial was conducted from June 2016 through June 2020. Of 3120 screened adults, 356 patients were eligible and enrolled, and 337 patients (mean age, 53.9; 141 [41.8%] women), randomized to 1300 mg TXA orally or 1000 mg TXA through IV (n = 168) vs placebo (n = 169) thrice daily for maximum 30 days. Three hundred thirty patients were activated when their platelet counts fell below 30 000 per µL; 279 (83%) had complete outcome ascertainment. World Health Organization (WHO) grade ≥2 bleeding was observed in the 30 days following activation in 50.3% (73/145) and 54.2% (78/144) of patients in the TXA and placebo groups, with an adjusted odds ratio of 0.83 (95% confidence interval [CI], 0.50-1.34; P = .44). There was no statistically significant difference in the mean number of platelet transfusions (mean difference, 0.1; 95% CI, -1.9 to 2.0), mean days alive without grade ≥2 bleeding (mean difference, 0.8; 95% CI, -0.4 to 2.0), thrombotic events (6/163 [3.7%] TXA, 9/163 [5.5%] placebo), or deaths due to serious bleeding. Most common adverse events were: diarrhea (116/164 [70.7%] TXA and 114/163 [69.9%] placebo); febrile neutropenia (111/164 [67.7%] TXA, 105/163 [64.4%] placebo); fatigue (106/164 [64.6%] TXA, 109/163 [66.9%] placebo); and nausea (104/164 [63.4%] TXA, 97/163 [59.5%] placebo). Among patients with hematologic malignancy undergoing chemotherapy or hematopoietic stem cell transplantation, prophylactic treatment with TXA compared with placebo did not significantly reduce the risk of WHO grade ≥2 bleeding.
Single tranexamic acid dose to reduce perioperative morbidity in primary total hip replacement: a randomised clinical trial. [2023]Although prophylactic tranexamic acid (TXA) is a safe, low-cost option to reduce bleeding in patients undergoing total hip replacement (THR), its optimal dose and duration is unknown. We compared the safety and effectiveness of TXA given as either a single injection or continuous infusion in THR patients, hypothesising that a second TXA dose would not offer any clinical advantages over the single injection.
Efficacy of local infiltration of tranexamic acid in subcutaneous surgery: A protocol from a single medical center. [2023]The purpose of this study was to explore efficacy of locally injected tranexamic acid (TXA) at a concentration of 1 mg/mL for reduction perioperative bleeding and postoperative complications in subcutaneous tumor excisions. We present the protocol and also compare results between the group of use antithrombotic group and not used.
The frequency of thrombotic events among adults given antifibrinolytic drugs for spontaneous bleeding: systematic review and meta-analysis of observational studies and randomized trials. [2022]The antifibrinolytic drug tranexamic acid (TXA) improves survival after trauma. Antifibrinolytic drugs may also improve outcome after spontaneous bleeding, so we conducted a systematic review of the frequency of thrombotic events associated with their use after spontaneous bleeding, to help design future randomized controlled trials.