Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.
This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status.
The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 1:1 randomization, given tranexamic acid during surgery, visual acuity exam |
|
| Placebo | Placebo Comparator | 1:1 randomization, given standard of care treatment during surgery, visual acuity exam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Antifibrinolytic Agent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion | The number of participants who had red blood cells (RBC) transfused:
| Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
| Blood Loss | Amount of blood loss:
| Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
| Delirium Occurrence | Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument. | Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium Severity | Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium) | Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
| Change in Interleukin-6 Concentration. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Olinger, M.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40276619 | Derived | Hindman BJ, Olinger CR, Woodroffe RW, Zanaty M, Deifelt Streese C, Zacharias ZR, Houtman JCD, Wendt LH, Ten Eyck PP, O'Connell-Moore DJ, Ray EJ, Lee SJ, Waldschmidt DF, Havertape LG, Nguyen LB, Chen PF, Banks MI, Sanders RD, Howard MA 3rd. Exploratory randomised trial of tranexamic acid to decrease postoperative delirium in adults undergoing lumbar fusion-a trial stopped early. BJA Open. 2025 Apr 14;14:100403. doi: 10.1016/j.bjao.2025.100403. eCollection 2025 Jun. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
37 subjects were excluded and not randomized due to the following reasons:
123 subjects were enrolled and consented. Prior to randomization, 37 subjects were excluded and did not get randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 1:1 randomization, given tranexamic acid during surgery, visual acuity exam Tranexamic Acid: Antifibrinolytic Agent Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
| FG001 | Placebo | 1:1 randomization, given standard of care treatment during surgery, visual acuity exam Saline Solution: Placebo Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 1:1 randomization, given tranexamic acid during surgery, visual acuity exam Tranexamic Acid: Antifibrinolytic Agent Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Transfusion | The number of participants who had red blood cells (RBC) transfused:
| Posted | Count of Participants | Participants | No | Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
|
Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 1:1 randomization, given tranexamic acid during surgery, visual acuity exam Tranexamic Acid: Antifibrinolytic Agent Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Blood and lymphatic system disorders | Non-systematic Assessment | Pulmonary embolism 22 days after surgery, after discharge. Determined not to be attributed to study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision Change | Eye disorders | Systematic Assessment | Temporary, unexplained vision change. Not attributed to study participation. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Olinger | University of Iowa | 319-384-5892 | catherine-olinger@uiowa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2022 | Mar 14, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2023 | Mar 14, 2024 | SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D003221 | Confusion |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
Not provided
Not provided
Not provided
| Saline Solution | Drug | Placebo |
|
| Visual Acuity Exam | Diagnostic Test | Supplemented into standard of care daily neurological exam on day of surgery and day after |
|
|
| 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) | Diagnostic Test | 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
|
Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw. |
| Preoperatively and 24 hours postoperatively |
| Length of Postoperative Stay Prior to Discharge | Length of postoperative stay prior to discharge in days | Days thru day of discharge |
| BG001 | Placebo | 1:1 randomization, given standard of care treatment during surgery, visual acuity exam Saline Solution: Placebo Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
1:1 randomization, given standard of care treatment during surgery, visual acuity exam Saline Solution: Placebo Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. |
|
|
| Primary | Blood Loss | Amount of blood loss:
| Posted | Median | Inter-Quartile Range | ml per instrumented vertebral level | Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
|
|
|
| Primary | Delirium Occurrence | Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument. | Posted | Number | participants with delirium | Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
|
|
|
| Secondary | Delirium Severity | Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium) | Posted | Median | Inter-Quartile Range | 3D-CAM Points | Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported |
|
|
|
| Secondary | Change in Interleukin-6 Concentration. | Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw. | Posted | Median | Inter-Quartile Range | pg per ml | Preoperatively and 24 hours postoperatively |
|
|
|
| Secondary | Length of Postoperative Stay Prior to Discharge | Length of postoperative stay prior to discharge in days | Posted | Median | Inter-Quartile Range | Days | Days thru day of discharge |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 6 |
| 43 |
| EG001 | Placebo | 1:1 randomization, given standard of care treatment during surgery, visual acuity exam Saline Solution: Placebo Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. | 0 | 40 | 2 | 40 | 6 | 40 |
|
| Embolic stroke | Nervous system disorders | Non-systematic Assessment | Embolic stroke 69 days after surgery, following discharge. Determined not to be attributed to study participation. |
|
|
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment | Creatinine increase > 20% of baseline on post-operative day 1. All resolved and not attributed to study participation. |
|
| Wound Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment | Delayed wound healing. Not attributed to study participation. |
|
Not provided
Not provided
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Either Intraoperatively or Postoperatively |
|