## Protocol Section
### Identification Module
**NCT ID:** NCT06427850

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

**Official Title:** Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 123678
#### Organization
**Class:** OTHER
**Full Name:** Ramathibodi Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Thanawan Longsuwan

#### Responsible Party

**Investigator Affiliation:** Ramathibodi Hospital

**Investigator Full Name:** Thanawan Longsuwan

**Investigator Title:** Doctor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** Detail : Randomization of Patients for intra-surgical site topical tranexamic acid injection

Objective : To compare the efficacy of topical tranexamic acid (TXA) injection into the surgical wound versus placebo injection in reducing blood loss and drainage output in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) surgery.

Methods:

Patient: Patients with degenerative spine conditions undergoing single-level MI-TLIF surgery, who received treatment at Ramathibodi Hospital and Chakri Naruebodindra Medical Institute from 2024 to 2027.

Randomization : Patients will be randomly by various block randomization (1:1) was performed using STATA 16.0 to ensure that the two groups were comparable in size and that the sequence of randomization was unpredictable.

Intervention :

Group 1 : Patients in this group will receive an injection of topical tranexamic acid (TXA) into the surgical site(50mg/ml) 10 ml after wound exposure and after wound decompression.

Group 2: Patients in this group will receive a placebo injection (Normal saline 10 ml) into the surgical site after wound exposure and after wound decompression.

Allocation Concealment :

A central randomization service will prepare sealed envelopes labeled with sequence numbers corresponding to the sample size. This method decreasing selection bias in assigning participants to the treatment groups. The envelopes were opened and equipment prepared after anesthesia was administered and before the surgeon began the incision.

Blinding :

The study participants and assessors will be blinded to treatment allocation. The surgeons were blinded by clear fluid as same in 2 groups but if tranexamic acid can be effective to decrease blood loss in intraoperation. So we cannot controlled blinding surgeons.

Primary outcome measurement: postoperative drainage (ml)

Secondary outcome measurement:

calculated total blood loss, intraoperative blood loss, blood transfusion rate, duration of drain maintenance, length of hospital stay, complication of tranexamic acid (TXA) and surgery.

Statistical Analysis:

Demographic Analysis :

For continuous data reported as Mean and Standard Deviation (S.D.) and analyzed by Independent t-test or Mann-Whitney U test.

For categorical data reported as Percentages and analyzed by Chi-square test.

Compare the results of the study:

Postoperative drainage (ml),calculated total blood loss (ml), intraoperative blood loss (mL) , duration of drain maintenance (day), length of hospital stay (day)were report to Mean and Standard Deviation (S.D.) analyzed by Independent t-test or Mann-Whitney U test for continuous data.

Complication of tranexamic acid (TXA) and surgery(%), blood transfusion rate (%) were reported to Percentages and analyzed by Chi-square test. Use STATA 16.0 software for statistical calculations.

### Conditions Module

**Conditions:**

- Degenerative Spine Diseases

- Surgical Wound

**Keywords:**

- Degenerative spine diseases

- Surgical wound

- Tranexamic acid (TXA)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** receive an injection of topical tranexamic acid (TXA) into the surgical site

**Intervention Names:**

- Drug: Tranexamic acid

**Label:** Topical tranexamic acid (TXA) injection

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** receive an injection Normal saline into the surgical site

**Intervention Names:**

- Drug: Normal saline

**Label:** Placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Topical tranexamic acid (TXA) injection

**Description:** receive an injection of Tranexamic acid into the surgical site

**Name:** Tranexamic acid

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo group

**Description:** receive an injection of Normal saline into the surgical site

**Name:** Normal saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Fluid drainage after operation

**Measure:** postoperative drainage (mL)

**Time Frame:** 120 hours

#### Secondary Outcomes

**Description:** calculated total blood loss by Gross formular

**Measure:** calculated total blood loss (mL)

**Time Frame:** 120 hours

**Description:** Evaluated by anesthesiologists

**Measure:** intraoperative blood loss (mL)

**Time Frame:** Intraoperative time

**Description:** Duration time of drain insertion to off drain

**Measure:** duration of drain maintenance (day)

**Time Frame:** 120 hours

**Description:** Duration time of patients stay in hospital

**Measure:** length of hospital stay (day)

**Time Frame:** 120 hours

**Description:** The patients who had complication from tranexamic acid (TXA) and surgery in each group

**Measure:** complication of tranexamic acid (TXA) and surgery(%)

**Time Frame:** 120 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 30-80 years old
* Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF

Exclusion Criteria:

* Revision surgery
* Patients who had high risk of complication from TXA
* History of seizure, PE, DVT, thromboembolic episode
* History of TXA allergy
* Patients who had high risk for bleeding
* U/D : CKD stage more than IIIb (GFR\< 45 ml/min/1.73m2), hepatic disease, bleeding disorder
* On anticoagulation drug or antiplatelet drug in 7 days before surgery
* Abnormal coagulation profile (INR \> 1.5) or CBC (platelet \< 100000)

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bland.demon3@gmail.com

**Name:** Thanawan Longsuwan, Doctor of medicine

**Phone:** (+66)892966855

**Role:** CONTACT

**Contact 2:**

**Name:** Kan Kaewroj, Diploma of Orthopaedics

**Phone:** (+66) 022011589

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: HIGH

- As Found: Spine Disease

- ID: M1112

- Name: Surgical Wound

- Relevance: HIGH

- As Found: Surgical Wound

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013122

- Term: Spinal Diseases

- ID: D000072836

- Term: Surgical Wound

### Intervention Browse Module - Ancestors

- ID: D000000933

- Term: Antifibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006490

- Term: Hemostatics

- ID: D000003029

- Term: Coagulants

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16902

- Name: Tranexamic Acid

- Relevance: HIGH

- As Found: Stage IV

- ID: M4252

- Name: Antifibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014148

- Term: Tranexamic Acid

### Misc Info Module

- Version Holder: 2024-05-31
