Chronic Sinusitis, Deviated Nasal Septum Acquired, Deviated Nasal Septum - Congenital, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane
Conditions
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.
Interventions
DRUGTranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
Medication administered 15 minutes prior to end of surgery.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Guaze Saturation VAS Though POD7 | Postoperative Day 2 through Postoperative Day 7 | Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood). |
| Bleeding VAS - POD1 | Postoperative Day 1 (assessed within first 24 hours following surgery) | Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Bleeding VAS - POD2 | Postoperative Day 2 | Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Bleeding VAS - POD3 | Postoperative Day 3 | Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Bleeding VAS - POD4 | Postoperative Day 4 | Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Bleeding VAS - POD5 | Postoperative Day 5 | Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Bleeding VAS - POD6 | Postoperative Day 6 | Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
| Bleeding VAS - POD7 | Postoperative Day 7 | Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Participant Follow-up | Day of surgery through 1 week | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline Participants continue to receive their normal saline infusion during surgery. | 19 |
| 1,000mg IV Tranexamic Acid 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | 1,000mg IV Tranexamic Acid | Total | Normal Saline |
|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 18.6 | 48.4 years STANDARD_DEVIATION 18.8 | 56.0 years STANDARD_DEVIATION 16.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 21 Participants | 40 Participants | 19 Participants |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Bleeding VAS - POD1
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD1 | 5.03 score on a scale | Standard Deviation 2.14 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD1 | 4.82 score on a scale | Standard Deviation 2.18 |
Comparison: Comparison of bleeding at day 1p-value: 0.8two sided Z-test
Primary
Bleeding VAS - POD2
Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time frame: Postoperative Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD2 | 4.47 score on a scale | Standard Deviation 2.61 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD2 | 3.89 score on a scale | Standard Deviation 2.01 |
Primary
Bleeding VAS - POD3
Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time frame: Postoperative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD3 | 2.93 score on a scale | Standard Deviation 2.44 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD3 | 2.29 score on a scale | Standard Deviation 1.21 |
Primary
Bleeding VAS - POD4
Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time frame: Postoperative Day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD4 | 2.12 score on a scale | Standard Deviation 2.04 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD4 | 1.44 score on a scale | Standard Deviation 1.23 |
Primary
Bleeding VAS - POD5
Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time frame: Postoperative Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD5 | 1.32 score on a scale | Standard Deviation 1.63 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD5 | 1.15 score on a scale | Standard Deviation 0.94 |
Primary
Bleeding VAS - POD6
Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time frame: Postoperative Day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD6 | 1.36 score on a scale | Standard Deviation 1.3 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD6 | 0.76 score on a scale | Standard Deviation 0.83 |
Primary
Bleeding VAS - POD7
Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Time frame: Postoperative Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Bleeding VAS - POD7 | 0.97 score on a scale | Standard Deviation 1.09 |
| 1,000mg IV Tranexamic Acid | Bleeding VAS - POD7 | 0.72 score on a scale | Standard Deviation 0.89 |
Primary
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).
Time frame: Postoperative Day 2 through Postoperative Day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline | Guaze Saturation VAS Though POD7 | Postoperative day 3 | 3.03 score on a scale | Standard Deviation 3.05 |
| Normal Saline | Guaze Saturation VAS Though POD7 | Postoperative day 2 | 5.16 score on a scale | Standard Deviation 2.89 |
| Normal Saline | Guaze Saturation VAS Though POD7 | Postoperative day 6 | 0.99 score on a scale | Standard Deviation 1.45 |
| Normal Saline | Guaze Saturation VAS Though POD7 | Postoperative day 4 | 1.74 score on a scale | Standard Deviation 2.1 |
| Normal Saline | Guaze Saturation VAS Though POD7 | Postoperative day 7 | 0.80 score on a scale | Standard Deviation 1.05 |
| Normal Saline | Guaze Saturation VAS Though POD7 | Postoperative day 5 | 1.11 score on a scale | Standard Deviation 1.56 |
| 1,000mg IV Tranexamic Acid | Guaze Saturation VAS Though POD7 | Postoperative day 7 | 0.28 score on a scale | Standard Deviation 0.57 |
| 1,000mg IV Tranexamic Acid | Guaze Saturation VAS Though POD7 | Postoperative day 2 | 4.56 score on a scale | Standard Deviation 2.5 |
| 1,000mg IV Tranexamic Acid | Guaze Saturation VAS Though POD7 | Postoperative day 3 | 2.09 score on a scale | Standard Deviation 1.81 |
| 1,000mg IV Tranexamic Acid | Guaze Saturation VAS Though POD7 | Postoperative day 4 | 0.76 score on a scale | Standard Deviation 1.34 |
| 1,000mg IV Tranexamic Acid | Guaze Saturation VAS Though POD7 | Postoperative day 5 | 0.40 score on a scale | Standard Deviation 0.86 |
| 1,000mg IV Tranexamic Acid | Guaze Saturation VAS Though POD7 | Postoperative day 6 | 0.29 score on a scale | Standard Deviation 1.81 |
Secondary
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
Time frame: Day of surgery through 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Saline | Frequency of Participant Follow-up | PACU | 0 Participants |
| Normal Saline | Frequency of Participant Follow-up | Follow-up visit | 0 Participants |
| Normal Saline | Frequency of Participant Follow-up | Follow-up phone call | 2 Participants |
| 1,000mg IV Tranexamic Acid | Frequency of Participant Follow-up | PACU | 0 Participants |
| 1,000mg IV Tranexamic Acid | Frequency of Participant Follow-up | Follow-up visit | 1 Participants |
| 1,000mg IV Tranexamic Acid | Frequency of Participant Follow-up | Follow-up phone call | 2 Participants |