Blood Loss, Pituitary Tumor, Surgery
Conditions
Brief summary
This trial is to determine the effect of Tranexamic Acid (TXA) on blood loss during endoscopic pituitary surgery. The hypothesis of this study is that TXA will reduce blood loss during surgery compared to a placebo. To answer this hypothesis, the investigators are conducting a randomized controlled trial in which half of participants will receive TXA and half will receive placebo (saline) in a double blind fashion.
Interventions
DRUGTranexamic acid
Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
DRUGPlacebo
Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The only staff with access to randomization codes will be our study statistician who created the randomization table and our investigational drug services pharmacy who is preparing the investigational product.
Intervention model description
Participants randomized to receive the investigational product vs placebo during a single study encounter.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Undergoing endoscopic pituitary surgery at UNC
Exclusion criteria
* Clival invasion * Giant pituitary tumor (\>4 cm) * Revision pituitary surgery * Prior sinus surgery * Lund McKay score \> 3 * Active thromboembolic disease * Coagulopathy * Concomitant pro-thrombotic medications * Concomitant use of anti-coagulants or anti-platelet agents * Subarachnoid hemorrhage * History of severe hypersensitivity to Tranexamic Acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Loss | Time between incision and surgical closure, an average of 3 to 3.5 hours | Blood loss measured in mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative Surgical Visibility - Wormald Scale Score | Duration of operation, up to 4 hours | Wormald scale (0-10): The Wormald grading scale is a validated grading tool to measure visual field quality during endoscopic endonasal procedures. Lower scores indicate less bleeding and better surgical visibility. 0 = No bleeding (optimal) 1. = 1-2 points of blood ooze 2. = 3-4 points of ooze 3. = 5-6 points of ooze 4. = 7-8 points of ooze 5. = 9-10 points of ooze 6. = \>10 points of ooze, obscuring field 7. = Mild field bleeding with slow post-nasal accumulation 8. = Moderate field bleeding with moderate post-nasal accumulation 9. = Moderate-severe field bleeding with rapid post-nasal accumulation 10. = Severe bleeding (worst) with nose filling rapidly These measurements will take place 6 times. During hours 1, 2, 3, and 4 of the surgery, as well as during sphenoidotomy and durotomy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Venous Thromboembolism | from time of intervention administration through 1 week after surgery | Absolute number of incident venous thromboembolism |
| Mean Duration of Surgery | Time between incision and surgical closure, an average of 3 to 3.5 hours | Measured in hours |
Outcome results
None listed