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Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)

ConditionsDegenerative Spine DiseasesSurgical Wound
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorThanawan Longsuwan

About this trial

The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 30-80 years old

Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF

Disqualifiers

Revision surgery

Patients who had high risk of complication from TXA

History of seizure, PE, DVT, thromboembolic episode

History of TXA allergy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic acid

    Drug

    receive an injection of Tranexamic acid into the surgical site

  • Normal saline

    Drug

    receive an injection of Normal saline into the surgical site

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Topical tranexamic acid (TXA) injectionExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

postoperative drainage (mL)

Fluid drainage after operation

Time frame
120 hours

Secondary outcomes

1

calculated total blood loss (mL)

calculated total blood loss by Gross formular

Time frame
120 hours
2

intraoperative blood loss (mL)

Evaluated by anesthesiologists

Time frame
Intraoperative time
3

duration of drain maintenance (day)

Duration time of drain insertion to off drain

Time frame
120 hours
4

length of hospital stay (day)

Duration time of patients stay in hospital

Time frame
120 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thanawan Longsuwan

Lead sponsor

Ramathibodi Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: