[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05053867":3,"trial-entities:NCT05053867":83,"trial-summary:NCT05053867":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":54,"locations":57,"central_contacts":75,"overall_officials":77,"references":79,"see_also_links":80},"NCT05053867","2019-0991","A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients","RECRUITING","2027-07-31","2026-07","2026-07-16","2022-10-14","M.D. Anderson Cancer Center","OTHER",true,"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.","Primary Objective: To assess the benefit of using nebulized tranexamic acid versus the standard of care on 30 day mortality.\n\nSecondary Objectives: To assess the following outcomes when using nebulized tranexamic acid versus the standard of care:\n\n1. 100 day, ICU and hospital mortality rate\n2. Ventilator days at day 30\n3. ICU and Hospital Length of Stay\n4. PaO2:FIO2 ratio (or SpO2:FIO2 ratio) changes over the first 14 days\n5. Time to resolution of pulmonary hemorrhage\n6. Rate of recurrence of pulmonary hemorrhage\n7. Rate of invasive procedures required to control pulmonary hemorrhage",[18,19],"Pulmonary Hemorrhage","Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},60,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","tranexamic acid","Inhaled",[34],"Group A: Inhaled tranexamic acid",{"type":13,"name":36,"description":37,"armGroupLabels":38},"Usual Care","Standard of Care",[39],"Group B: Usual Care",[41],{"measure":42,"description":43,"timeFrame":44},"28 day all-cause mortality rate","Number of patients who are alive at 28 days following randomization. The difference between 28-day mortality rates between treatment arms will be computed along with a 95% confidence interval (CI) using the approximate standard error reported in Fleiss (1981). Logistic regression will be used to estimate the association between 28-day mortality and study covariates of interest.","up to 28 days",[],"ALL","18 Years",null,false,{"inclusion":51,"exclusion":52,"raw_text":53},[],[],"Inclusion Criteria:\n\n1. Age \\> 18 years old\n2. Have a diagnosed hematological malignancy\n3. Are actively receiving mechanical ventilation\n4. Have evidence of pulmonary hemorrhage as defined by either\n\n   1. Persistently bloody secretions upon endotracheal tube suctioning, or\n   2. Evidence of diffuse alveolar hemorrhage by bronchoscopic examination\n5. Signed informed consent by patient or if the subject lacks decision-making capacity, the subject's legally authorized representative\n\n2.3.2 Exclusion Criteria\n\nPatients excluded from participation in the study if any of the following criteria are met:\n\n1. Presence of a Do Not Resuscitate (DNR), no escalation of care or comfort care order at the time of screening\n2. Expected survival \\\u003C 48 hours\n3. Evidence of nasal or oral spillage likely to be the cause of bloody secretions\n4. Patients requiring 100% FIO2\n5. Known hypersensitivity to tranexamic acid\n6. Treatment with inhaled tranexamic acid prior to screening\n7. Acquired defective color vision\n8. Subarachnoid hemorrhage\n9. Deep Venous or arterial thrombus diagnosed within the previous 3 months\n10. Seizure disorder on active anti-epileptic therapies\n11. Hypersensitivity to tranexamic acid or any of the ingredients\n12. Pregnant women will not be eligible and have a negative pregnancy test prior to entering study\n13. Patient receiving concurrent anti-fibrinolytic therapy\n14. Confirmed active COVID-19 infection",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":72},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"Nisha Rathi, MD","CONTACT","713-745-5787","nrathi@mdanderson.org",{"name":66,"role":71},"PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},29.76328,-95.36327,[76],{"name":66,"role":67,"phone":68,"email":69},[78],{"name":66,"affiliation":12,"role":71},[],[81],{"label":59,"url":82},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":84,"biomarkers":86},[85,18],"Hematologic Neoplasm",[],{"nct_id":4,"found":14,"summary":88,"prompt_version":98},{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is a randomized controlled trial, meaning participants will be assigned by chance to receive either inhaled tranexamic acid or usual care. The study plans to enroll 60 participants.","completed","Inhaled Tranexamic Acid for Pulmonary Hemorrhage in Cancer Patients","This study is testing if inhaled tranexamic acid can help cancer patients who are experiencing pulmonary hemorrhage (bleeding in the lungs) and need a breathing machine. Researchers will compare inhaled tranexamic acid to usual care (standard treatment) to see if it improves survival within 28 days. You might be able to join if you are over 18, have a blood cancer, are on a breathing machine, and have signs of bleeding in your lungs. The study aims to enroll 60 patients. The current recruitment status is unclear.","The main goal is to measure survival up to 28 days after treatment. Other outcomes will be tracked for up to 100 days.",87,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]