TXA in Spinal Fusion

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04272606
• Other study ID #: 201912099
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 18-90 years

2. American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV

3. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.

4. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.

Exclusion Criteria:

1. ASA class V

2. Patient unable to consent

3. Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL

4. Patient with known liver failure

5. Patients on anticoagulation or dual antiplatelets (presence of vascular stents).

6. Patients with artificial valves.

7. Patients with allergy to TXA

8. Patients with platelet count < 150 000,

9. Patients with PT>15s

10. Patients with Activated Partial Thromboplastin Time (APPT) >38s

11. History of stroke or (an) unprovoked thromboembolic event(s).

12. History of intracranial bleeding,

13. Pregnancy

14. known defective color vision

15. history of venous or arterial thromboembolism or active thromboembolic disease

16. Patients with severe pulmonary or cardiac disease.

17. Patients who refuse transfusion of blood products

18. Patients with chronic anemia with Hg<8

19. Patients undergoing lumbar fusion for disease other than DDD (neoplasm)

20. Patients undergoing lumbar fusion by anterior or lateral approach.

21. Minimally invasive TLIF are excluded.

22. Emergent cases.

23. Women on hormonal contraception

24. Retinal vein or artery occlusion

25. Hypercoagulability

26. Seizure disorder

27. Current use of tretinoin

28. Current use of chlorpromazine

29. Breast feeding

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Drug:
• Tranexamic Acid
Antifibrinolytic Agent
• Saline Solution
Placebo

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Catherine R. Olinger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion	The number of participants who had red blood cells (RBC) transfused: Intraoperatively; Postoperatively (prior to discharge or at day 5, whichever occurred first); Either Intraoperatively or Postoperatively	Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Primary	Blood Loss	Amount of blood loss: Intraoperatively; Postoperatively (prior to discharge or at day 5, whichever occurred first); Either Intraoperatively or Postoperatively	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.	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)	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.	Preoperatively and 24 hours postoperatively
Secondary	Length of Postoperative Stay Prior to Discharge	Length of postoperative stay prior to discharge in days	Days thru day of discharge