Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study

Liran Levy

Status and phase: Unknown; Phase 2

Conditions: Bronchoscopy Biopsy

Treatments: Drug: saline; Drug: tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02219152

0321-14

Details and patient eligibility

About

Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.

Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.

The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient that are candidates to endobronchial or transcronchial biopsy

Exclusion criteria

• S/P MI or CVA or PE or DVT .
• S/P thrombophilia.
• Patients under coagulation therpay
• Chronic Renal Failure
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups, including a placebo group

tranexamic acid

Experimental group

Description:

tranexamic acid will be administrated using the bronchoscope

Treatment:

Drug: tranexamic acid

saline

Placebo Comparator group

Description:

the saline will be administrated using an infusion during the biopsy.

Treatment:

Drug: saline