Inhaled Tranexamic Acid or Terlipressin for Treating Hemoptysis
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
This study is testing if inhaled Tranexamic Acid or Terlipressin can help people who cough up blood feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04961528 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of inhaled Tranexamic Acid (TXA) and Terlipressin (TER) in rapidly controlling hemoptysis, a condition characterized by coughing up blood. It is a randomized, double-blind, multicenter trial comparing these treatments against a placebo in patients experiencing mild to severe hemoptysis. The study aims to assess both the efficacy and safety of these medications administered via inhalation, which has not been previously evaluated for this condition. Participants will receive treatment for five days, with careful monitoring for side effects during their hospital stay.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with mild to severe hemoptysis lasting less than 7 days.
Not a fit: Patients requiring mechanical ventilation or those with contraindications to TXA or TER will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from hemoptysis.
How similar studies have performed: While the approach of using inhaled TXA or TER is novel, previous studies have shown the effectiveness of these drugs in other bleeding scenarios, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years, under 90 years * Mild to severe hemoptysis that has been going on for less than 7 days * Total expectorate blood ranging from 50 ml to 200 ml * Admission in emergency department or ICU for less than 12 hours * Social security affiliation * Signed informed consent * For child-bearing aged women, efficient contraception includes oral oestrogen- progestin, oral progestin, progestin implants and all types of intrauterine devices Exclusion Criteria: * Need for mechanical ventilation * Cystic fibrosis * Pregnancy or breast feeding * Contraindication for contrast agents injection (renal failure with creatinin clearance \< 30mL/min, know allergy to contrast agents injection) * Known hypersensitivity to TXA or TER or one of its excipients * Know previous cardiac arrhythmia (atrial fibrillation, atrial flutter..) * Contraindication to TXA (including renal failure with creatinin clearance \< 30mL/min) or TER therapy : * acute myocardial infarction in the 6 past months, * intrathecal injection in the 3 past months, * seizure in the past 3 months * Participation in another interventional study or being in the exclusion period at the end of a previous study. * Patient under tutorship or / guardianship, and incapable to give informed consent
Where this trial is running
Paris
- AP-HP, Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
Study contacts
- Study coordinator: Karine Goude-Ory
- Email: karine.goude@aphp.fr
- Phone: 01 44 84 17 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.