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Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery

Primary Purpose

Chronic Sinusitis, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to undergo elective sinus or nasal surgery (e.g. septoplasty, inferior turbinate reduction, endoscopic sinus surgery)
  • Age 18 or greater
  • English-speaking
  • Able to provide consent

Exclusion Criteria:

  • Minors (age<18)
  • Pregnant or may become pregnant by time of surgery
  • Prisoners
  • Non-English speaking
  • Foreign citizens
  • Unable to provide consent
  • Known pro-thrombotic coagulation disorders
  • Active intranasal drug use (e.g. cocaine)
  • Surgery is for a sinonasal tumor or other sinus pathology not described in inclusion criteria
  • Enrollment is in conflict with existing study participation

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1,000mg IV Tranexamic acid

Normal saline

Arm Description

Participants in this arm will be given a 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery.

Participants in this arm will not be given any extra intervention over their routine anesthetic care. They will continue to receive their normal saline infusion during surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery.

Outcomes

Primary Outcome Measures

Bleeding VAS - POD1
Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD2
Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD3
Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD4
Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD5
Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD6
Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD7
Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Guaze Saturation VAS Though POD7
Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood).

Secondary Outcome Measures

Frequency of Participant Follow-up
Number of patients in each arm requiring evaluation by the resident service for bleeding concerns expressed by the recovery nurse (in PACU), had any follow-up visit or phone call outside of regularly scheduled follow-up

Full Information

First Posted
February 10, 2021
Last Updated
March 9, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04754230
Brief Title
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Official Title
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Actual)
Study Completion Date
February 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate surgery). This medication has been shown to decrease blood loss during this type of surgery, but the implications for bleeding following surgery are unclear. Any impact on postoperative bleeding will be assessed over the first 7 days following surgery leading up to the first scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of their bleeding. The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each day after surgery. The secondary outcomes include the the frequency with which the otolaryngology resident service is requested to evaluate patients in the recovery unit for postoperative bleeding concerns and the frequency of interventions such as application of hemostatic materials, packing, cautery, and/or return to the operating room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane, Deviated Nasal Septum - Congenital, Deviated Nasal Septum Acquired

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1,000mg IV Tranexamic acid
Arm Type
Experimental
Arm Description
Participants in this arm will be given a 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery.
Arm Title
Normal saline
Arm Type
No Intervention
Arm Description
Participants in this arm will not be given any extra intervention over their routine anesthetic care. They will continue to receive their normal saline infusion during surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
Intervention Description
Medication administered 15 minutes prior to end of surgery.
Primary Outcome Measure Information:
Title
Bleeding VAS - POD1
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 1 (assessed within first 24 hours following surgery)
Title
Bleeding VAS - POD2
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 2
Title
Bleeding VAS - POD3
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 3
Title
Bleeding VAS - POD4
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 4
Title
Bleeding VAS - POD5
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 5
Title
Bleeding VAS - POD6
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 6
Title
Bleeding VAS - POD7
Description
Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time Frame
Postoperative Day 7
Title
Guaze Saturation VAS Though POD7
Description
Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood).
Time Frame
Postoperative Day 2 through Postoperative Day 7
Secondary Outcome Measure Information:
Title
Frequency of Participant Follow-up
Description
Number of patients in each arm requiring evaluation by the resident service for bleeding concerns expressed by the recovery nurse (in PACU), had any follow-up visit or phone call outside of regularly scheduled follow-up
Time Frame
Day of surgery through 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo elective sinus or nasal surgery (e.g. septoplasty, inferior turbinate reduction, endoscopic sinus surgery) Age 18 or greater English-speaking Able to provide consent Exclusion Criteria: Minors (age<18) Pregnant or may become pregnant by time of surgery Prisoners Non-English speaking Foreign citizens Unable to provide consent Known pro-thrombotic coagulation disorders Active intranasal drug use (e.g. cocaine) Surgery is for a sinonasal tumor or other sinus pathology not described in inclusion criteria Enrollment is in conflict with existing study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zara M. Patel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No current plan to share data.
Citations:
PubMed Identifier
24260760
Citation
Pundir V, Pundir J, Georgalas C, Fokkens WJ. Role of tranexamic acid in endoscopic sinus surgery - a systematic review and meta-analysis. Rhinology. 2013 Dec;51(4):291-7. doi: 10.4193/Rhino13.042. Erratum In: Rhinology. 2014 Mar;52(1):77.
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
22137511
Citation
Alimian M, Mohseni M. The effect of intravenous tranexamic acid on blood loss and surgical field quality during endoscopic sinus surgery: a placebo-controlled clinical trial. J Clin Anesth. 2011 Dec;23(8):611-5. doi: 10.1016/j.jclinane.2011.03.004.
Results Reference
background
PubMed Identifier
30593688
Citation
Kim DH, Kim S, Kang H, Jin HJ, Hwang SH. Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review. Laryngoscope. 2019 Apr;129(4):800-807. doi: 10.1002/lary.27766. Epub 2018 Dec 28.
Results Reference
background
PubMed Identifier
33522019
Citation
El-Ozairy HSE, Mady OM, Tawfik GM, Elhennawy AM, Teaima AA, Ebied A, Huy NT. Outcomes of combined use of topical and intravenous tranexamic acid on surgical field quality during functional endoscopic sinus surgery: Randomized controlled trial. Head Neck. 2021 May;43(5):1389-1397. doi: 10.1002/hed.26610. Epub 2021 Jan 31.
Results Reference
background
PubMed Identifier
36608352
Citation
Khanwalkar A, Chan E, Roozdar P, Kim D, Ma Y, Hwang PH, Nayak JV, Patel ZM. Tranexamic acid does not significantly lower postoperative bleeding after endoscopic sinus and nasal surgery. Int Forum Allergy Rhinol. 2023 Sep;13(9):1584-1591. doi: 10.1002/alr.23127. Epub 2023 Feb 6.
Results Reference
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Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery

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