| CTRI Number |
CTRI/2025/03/082166 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of high dose tranexamic acid versus standard dose of tranexamic acid to decrease blood loss in spine surgeries |
|
Scientific Title of Study
|
Comparison of the effect of tranexamic acid- high verses standard dose upon
intraoperative and postoperative blood loss in patients undergoing open Spine surgery -A Double
blinded randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Room no: 44, Ground Floor, Department of Orthopaedics, OPD Complex, AIIMS Patna, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
8877759220 |
| Fax |
|
| Email |
adityakumar0013@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabhat Agrawal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room no: 47, Ground Floor, Department of Orthopaedics, OPD Complex, AIIMS Patna, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
9811663869 |
| Fax |
|
| Email |
drprabhatagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhat Agrawal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room no: 47, Ground Floor, Department of Orthopaedics, OPD Complex, AIIMS Patna, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
9811663869 |
| Fax |
|
| Email |
drprabhatagrawal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Room no: 44, Ground Floor, Department of Orthopaedics, OPD Complex, AIIMS Patna, Phulwarisharif, Patna, Bihar, 801507 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aditya Kumar |
AIIMS Patna |
OT No 14 and 19, B Block, OT Complex, AIIMS Patna
Patna
BIHAR |
8877759220
adityakumar0013@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
patients in the group received high dose iv tranexamic acid |
patients in this group received high dose tranexamic acid (50mg/kg) |
| Comparator Agent |
patients in the group received standard dose tranexamic acid |
patients in the group received standard dose tranexamic acid (10mg/kg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Skeletally mature patients with preop hemoglobin more than 10 mg/dl with vertebral fractures, degenerative disc diseases, spondylodiscitis who needs open spine surgery.
2.People with normal levels of PT with INR and Aptt levels
|
|
| ExclusionCriteria |
| Details |
1.Elevated PT, PTT, INR for any reason
2.Patients with cervical disc disease and cervical vertebral fracture who needs anterior cervical diskectomy and fusion.
3.Patients who need single level lumbar diskectomy, single level spine decompression for lumbar canal stenosis.
4.Patients with pathological fractures, intradural tumor and spine deformity
5.History of thrombotic events such as CVA and MI
6.History of bleeding disorder
7.History of traumatic brain injury and CPR
8.Cancer, or any other serious illness that affects treatment evaluation
9.Renal failure with GFR lower than 60 ml/min
10.Use of anticoagulants such as aspirin and dipyridamole
11.OCP consumption, pregnancy, or lactation
12.Revision spine surgery
13.Patient with intraoperative Dural tears
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Blood loss intraoperatively
2.Blood loss postoperatively
|
1.Intraoperatively
2.Postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The complications associated with the use of Tranexamic acid in spine surgery.
2.Relation between TXA dosage with hospital stay.
 
|
1. Intraoperative
2. Postoperative |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary purpose of the study is to compare the efficacy of high-dose (50mg/kg body wt. followed with 5mg/kg/hr for 5 hours) versus standard-dose(10mg/kg body wt. followed with 1mg/kg/hr for 5 hours) Tranexamic Acid in reducing blood loss during single and double-level open spine.Also to assess secondary outcomes like blood transfusion rates, surgical complications, length of hospital stay, and cost-effectiveness.
Research hypothesis is High dose use of Tranaxamic acid is better than the standard dose used in single and double level spine surgeries. |