BridgeMD
New treatment option for Blood Loss, Surgical
Official title Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
ClinicalTrials.gov ID: NCT06725732
What this study is testing
What is Tranexamic Acid (TXA)?
Tranexamic Acid (TXA) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for blood loss, surgical.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS. Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome 1.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Either sex
- age 18-65 years
- ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
- normal accepted coagulation profile and hematocrit value ≥30
You likely can't join if
- chronic renal failure
- liver cirrhosis
- bleeding disorders
- current anticoagulant therapy
- pregnancy or breastfeeding
- impaired color vision
See the full eligibility criteria
- Either sex
- age 18-65 years
- ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
- normal accepted coagulation profile and hematocrit value ≥30
- chronic renal failure
- liver cirrhosis
- bleeding disorders
- current anticoagulant therapy
- pregnancy or breastfeeding
- impaired color vision
- severe vascular ischemia
- history of venous thrombosis, pulmonary embolism
- long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery
- hemoglobin (HB) concentration \<10 mg/dl \_allergy to TXA.
- BMI \> 35 kg/ m2
The study team makes the final eligibility decision.
Where it's taking place
- Asyut, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Asyut, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.