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Search / Trial NCT06422273

Protest Trial: TXA vs Saline

Launched by SPECTRUM HEALTH HOSPITALS · May 17, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practic...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Single or double lung transplant recipients
  • 2. Patients \>18 years old
  • 3. Willingness and ability to sign an informed consent for study participation
  • Exclusion Criteria:
  • 1. Platelet count (\<50k/uL)
  • 2. INR (\>1.6)
  • 3. Active bleeding
  • 4. Decompensated liver disease
  • 5. History of uremic bleeding or BUN \>50
  • 6. Severe pulmonary hypertension (mean PA pressure \>40 mmHg on RHC or estimated PA systolic pressure \>62 mmHg on TTE within one year of procedure)
  • 7. Known bleeding disorder
  • 8. Allergy to TXA
  • 9. Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention)
  • 10. Contraindications to topical TXA
  • 11. Pregnancy
  • 12. Vulnerable populations
  • 13. Adults of limited English proficiency/non-English speakers

About Spectrum Health Hospitals

Spectrum Health Hospitals is a leading healthcare provider dedicated to delivering high-quality patient care and advancing medical research through innovative clinical trials. As a part of a comprehensive health system, Spectrum Health Hospitals integrates cutting-edge technology and evidence-based practices to enhance patient outcomes and contribute to the broader medical community. With a commitment to ethical standards and patient safety, Spectrum Health Hospitals actively engages in diverse clinical research initiatives, fostering collaboration among healthcare professionals, researchers, and participants to drive advancements in treatment and therapeutic options.

Locations

Grand Rapids, Michigan, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported