Pituitary TumorPhase 2NCT04863339
Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
A Phase 2 study testing Tranexamic acid in people with Pituitary Tumor and Blood Loss, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pituitary Tumor, Blood Loss, Surgery
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing endoscopic pituitary surgery at UNC
Who cannot join
- Clival invasion
- Giant pituitary tumor (>4 cm)
- Revision pituitary surgery
- Prior sinus surgery
- Lund McKay score > 3
- Active thromboembolic disease
Show all 11Show fewer
- Coagulopathy
- Concomitant pro-thrombotic medications
- Concomitant use of anti-coagulants or anti-platelet agents
- Subarachnoid hemorrhage
- History of severe hypersensitivity to Tranexamic Acid
About this study
Official title: Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
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.
- Conditions
- Pituitary Tumor, Blood Loss, Surgery
- Being tested
- Tranexamic acid, Placebo
- Medical subject headings
- Pituitary Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
PlaceboDrug
Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid. Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | Patients in the placebo arm will receive a saline placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Blood Loss
Blood loss measured in mL
Measured: Time between incision and surgical closure, an average of 3 to 3.5 hours
Secondary outcomes (1)
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.
Measured: Duration of operation, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study startMar 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: Challenges in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to receive the investigational product vs placebo during a single study encounter.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Senior, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863339
- Sponsor's protocol ID
- 20-2267
- Status last verified
- Mar 2022
- First submitted
- 23 Apr 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23477634Ping 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.
PubMed 31008946Heyns 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.
PubMed 32224739Jahanshahi 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.
PubMed 25133491Mebel 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.
PubMed 26554461
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04863339
- Acronym / sponsor ID
- 20-2267
- Conditions
- Pituitary Tumor, Blood Loss, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Challenges in recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized to receive the investigational product vs placebo during a single study encounter.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic acidParticipants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in the placebo arm will receive a saline placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing endoscopic pituitary surgery at UNC
Key exclusion criteria (11 listed)
- Clival invasion
- Giant pituitary tumor (>4 cm)
- Revision pituitary surgery
- Prior sinus surgery
- Lund McKay score > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidSingle preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery. | Drug | Tranexamic Acid |
| PlaceboSingle preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery. | Drug | Placebo |
Primary outcome
Mean Blood Loss
Time frame: Time between incision and surgical closure, an average of 3 to 3.5 hours
Blood loss measured in mL
1 secondary outcome
Intra-operative Surgical Visibility - Wormald Scale Score
Time frame: Duration of operation, up to 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 23477634Roberts 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.
- Background: PubMed 31008946Ping 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.
- Background: PubMed 32224739Heyns 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.
- Background: PubMed 25133491Jahanshahi 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.
- Background: PubMed 26554461Mebel 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Senior, MD principal investigator
UNC Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid in people with Pituitary Tumor and Blood Loss, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Blood Loss (time frame: Time between incision and surgical closure, an average of 3 to 3.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863339, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.