Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
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|ClinicalTrials.gov Identifier: NCT04863339|
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : September 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Tumor Blood Loss Surgery||Drug: Tranexamic acid Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants randomized to receive the investigational product vs placebo during a single study encounter.|
|Masking:||Quadruple (Participant, Care Provider, 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.|
|Official Title:||Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: Tranexamic Acid
Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
Drug: Tranexamic acid
Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
Placebo Comparator: Placebo
Patients in the placebo arm will receive a saline placebo.
Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.
- Mean Blood Loss [ Time Frame: Time between incision and surgical closure, an average of 3 to 3.5 hours ]Blood loss measured in mL
- Intra-operative Surgical Visibility - Wormald Scale Score [ Time Frame: 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)
- = 1-2 points of blood ooze
- = 3-4 points of ooze
- = 5-6 points of ooze
- = 7-8 points of ooze
- = 9-10 points of ooze
- = >10 points of ooze, obscuring field
- = Mild field bleeding with slow post-nasal accumulation
- = Moderate field bleeding with moderate post-nasal accumulation
- = Moderate-severe field bleeding with rapid post-nasal accumulation
- = 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.
- Incidence of Venous Thromboembolism [ Time Frame: from time of intervention administration through 1 week after surgery ]Absolute number of incident venous thromboembolism
- Mean Duration of Surgery [ Time Frame: Time between incision and surgical closure, an average of 3 to 3.5 hours ]Measured in hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863339
|Contact: Brent Senior, MD||919-966-3344||Brent_Senior@med.unc.edu|
|United States, North Carolina|
|UNC Chapel Hil||Recruiting|
|Chapel Hill, North Carolina, United States, 27514|
|Contact: Brent Senior, MD 919-966-3344 Brent_Senior@med.unc.edu|
|Principal Investigator:||Brent Senior, MD||UNC Chapel Hill|