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TXA in Spinal Fusion

Primary Purpose

Degenerative Disc Disease

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tranexamic Acid

Saline Solution

Visual Acuity Exam

3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Posterior Lumbar Interbody Fusion, Transforaminal Lumbar Interbody Fusion, Tranexamic Acid, Neurosurgery, Delirium

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-90 years
American Spinal Injury Association (ASIA) Impairment Scale anesthesia risk of I to IV
Body Mass Index (BMI) of<35
Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.

Exclusion Criteria:

ASIA class V
Patient unable to consent
Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL
Patient with known liver failure
Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
Patients with artificial valves.
Patients with allergy to TXA
Patients with platelet count < 150 000,
Patients with PT<60%
Patients with Activated Partial Thromboplastin Time (APPT) >38s
History of stroke or (an) unprovoked thromboembolic event(s).
History of intracranial bleeding,
Pregnancy
known defective color vision
history of venous or arterial thromboembolism or active thromboembolic disease
Patients with severe pulmonary or cardiac disease.
Patients who refuse transfusion of blood products
Patients with chronic anemia with Hg<8
Patients undergoing lumbar fusion for disease other than DDD (neoplasm)
Patients undergoing lumbar fusion by anterior or lateral approach.
Minimally invasive TLIF are excluded.
Emergent cases.

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

1:1 randomization, given tranexamic acid during surgery, visual acuity exam

1:1 randomization, given standard of care treatment during surgery, visual acuity exam

Outcomes

Primary Outcome Measures

Transfusion

Amount (in cells cubed) of red blood cells (RBC) transfused intraoperatively and up to 7 days post-operatively

Blood Loss

Amount (in cells cubed) of blood loss intraoperatively and up to 7 days post-operatively

Delirium

Delirium incidence (yes/no) and severity (score 0-20) using daily 3D-CAM delirium assessment instrument.

Secondary Outcome Measures

Full Information

NCT ID

NCT04272606

First Posted

February 13, 2020

Last Updated

June 6, 2023

Sponsor

Catherine R. Olinger

1. Study Identification

Unique Protocol Identification Number

NCT04272606

Brief Title

TXA in Spinal Fusion

Official Title

Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Catherine R. Olinger

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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 incidence and severity will be assessed daily for the first 5 days after surgery and at discharge. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease

Keywords

Posterior Lumbar Interbody Fusion, Transforaminal Lumbar Interbody Fusion, Tranexamic Acid, Neurosurgery, Delirium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

1:1 randomization, given tranexamic acid during surgery, visual acuity exam

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

1:1 randomization, given standard of care treatment during surgery, visual acuity exam

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Other Intervention Name(s)

Cyklokapron

Intervention Description

Antifibrinolytic Agent

Intervention Type

Drug

Intervention Name(s)

Saline Solution

Intervention Description

Placebo

Intervention Type

Diagnostic Test

Intervention Name(s)

Visual Acuity Exam

Other Intervention Name(s)

Eye Exam

Intervention Description

Supplemented into standard of care daily neurological exam on day of surgery and day after

Intervention Type

Diagnostic Test

Intervention Name(s)

3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

Intervention Description

3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.

Primary Outcome Measure Information:

Title

Transfusion

Description

Amount (in cells cubed) of red blood cells (RBC) transfused intraoperatively and up to 7 days post-operatively

Time Frame

Up to 7 days

Title

Blood Loss

Description

Amount (in cells cubed) of blood loss intraoperatively and up to 7 days post-operatively

Time Frame

Up to 7 days or until discharge

Title

Delirium

Description

Delirium incidence (yes/no) and severity (score 0-20) using daily 3D-CAM delirium assessment instrument.

Time Frame

up to 7 days or discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-90 years American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections. Exclusion Criteria: ASA class V Patient unable to consent Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL Patient with known liver failure Patients on anticoagulation or dual antiplatelets (presence of vascular stents). Patients with artificial valves. Patients with allergy to TXA Patients with platelet count < 150 000, Patients with PT>15s Patients with Activated Partial Thromboplastin Time (APPT) >38s History of stroke or (an) unprovoked thromboembolic event(s). History of intracranial bleeding, Pregnancy known defective color vision history of venous or arterial thromboembolism or active thromboembolic disease Patients with severe pulmonary or cardiac disease. Patients who refuse transfusion of blood products Patients with chronic anemia with Hg<8 Patients undergoing lumbar fusion for disease other than DDD (neoplasm) Patients undergoing lumbar fusion by anterior or lateral approach. Minimally invasive TLIF are excluded. Emergent cases. Women on hormonal contraception Retinal vein or artery occlusion Hypercoagulability Seizure disorder Current use of tretinoin Current use of chlorpromazine Breast feeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Olinger, M.D.

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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