Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
Primary Purpose
Pituitary Tumor, Blood Loss, Surgery
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
About this trial
This is an interventional other trial for Pituitary Tumor
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid
Placebo
Arm Description
Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
Patients in the placebo arm will receive a saline placebo.
Outcomes
Primary Outcome Measures
Mean Blood Loss
Blood loss measured in mL
Secondary Outcome Measures
Intra-operative Surgical Visibility - Wormald Scale Score
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.
Full Information
NCT ID
NCT04863339
First Posted
April 23, 2021
Last Updated
March 25, 2022
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04863339
Brief Title
Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
Official Title
Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Challenges in recruitment
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Tumor, Blood Loss, Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized to receive the investigational product vs placebo during a single study encounter.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the placebo arm will receive a saline placebo.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.
Primary Outcome Measure Information:
Title
Mean Blood Loss
Description
Blood loss measured in mL
Time Frame
Time between incision and surgical closure, an average of 3 to 3.5 hours
Secondary Outcome Measure Information:
Title
Intra-operative Surgical Visibility - Wormald Scale Score
Description
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.
Time Frame
Duration of operation, up to 4 hours
Other Pre-specified Outcome Measures:
Title
Incidence of Venous Thromboembolism
Description
Absolute number of incident venous thromboembolism
Time Frame
from time of intervention administration through 1 week after surgery
Title
Mean Duration of Surgery
Description
Measured in hours
Time Frame
Time between incision and surgical closure, an average of 3 to 3.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Senior, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
12 to 24 months following publication
IPD Sharing Access Criteria
Requests for IPD can be made by email and will be reviewed by the PI. The study protocol and deidentified data can be provided for scientific analyses performed by physicians and researchers affiliated with academic institutions.
Citations:
PubMed Identifier
23477634
Citation
Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
Results Reference
background
PubMed Identifier
31008946
Citation
Ping WD, Zhao QM, Sun HF, Lu HS, Li F. Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial. Medicine (Baltimore). 2019 Apr;98(16):e15202. doi: 10.1097/MD.0000000000015202.
Results Reference
background
PubMed Identifier
32224739
Citation
Heyns M, Knight P, Steve AK, Yeung JK. A Single Preoperative Dose of Tranexamic Acid Reduces Perioperative Blood Loss: A Meta-analysis. Ann Surg. 2021 Jan 1;273(1):75-81. doi: 10.1097/SLA.0000000000003793.
Results Reference
background
PubMed Identifier
25133491
Citation
Jahanshahi J, Hashemian F, Pazira S, Bakhshaei MH, Farahani F, Abasi R, Poorolajal J. Effect of topical tranexamic acid on bleeding and quality of surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a triple blind randomized clinical trial. PLoS One. 2014 Aug 18;9(8):e104477. doi: 10.1371/journal.pone.0104477. eCollection 2014.
Results Reference
background
PubMed Identifier
26554461
Citation
Mebel D, Akagami R, Flexman AM. Use of Tranexamic Acid Is Associated with Reduced Blood Product Transfusion in Complex Skull Base Neurosurgical Procedures: A Retrospective Cohort Study. Anesth Analg. 2016 Feb;122(2):503-8. doi: 10.1213/ANE.0000000000001065.
Results Reference
background
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Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
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