| CTRI Number |
CTRI/2012/01/002357 [Registered on: 20/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
20/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Drug to control bleeding in major spine surgery |
|
Scientific Title of Study
|
Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery        |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rupinder Pal Singh Chahal |
| Designation |
Consultant |
| Affiliation |
Sir ganga Ram Hospital |
| Address |
Room 1412, Department of Spine Surgery
Sir ganga ram Hospital
New Delhi
Old Rajinder Nagar
New Delhi 110060
Central
DELHI
110060
India |
| Phone |
9212545550 |
| Fax |
|
| Email |
rupinder72@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupinder Pal Singh Chahal |
| Designation |
Consultant |
| Affiliation |
Sir ganga Ram Hospital |
| Address |
Room 1412, Department of Spine Surgery
Sir ganga ram Hospital
New Delhi
Old Rajinder Nagar
New Delhi 110060
Central
DELHI
110060
India |
| Phone |
9212545550 |
| Fax |
|
| Email |
rupinder72@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupinder Pal Singh Chahal |
| Designation |
Consultant |
| Affiliation |
Sir ganga Ram Hospital |
| Address |
Room 1412, Department of Spine Surgery
Sir ganga ram Hospital
New Delhi
Old Rajinder Nagar
New Delhi 110060
Central
DELHI
110060
India |
| Phone |
9212545550 |
| Fax |
|
| Email |
rupinder72@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AOSpine India |
| Address |
38, engineers enclave Pitampura
New Delhi |
| Type of Sponsor |
Other [medical education and research body ] |
|
|
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 |
| Dr Rupinder pal Singh Chahal |
Department of Spine Surgery |
Room 1412, sir Ganga Ram Hospital
Central
DELHI |
9212545550
rupinder72@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients requiring Spine fusion surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline (NaCl 0.9%) |
Bolus dose of normal saline (NaCl 0.9%) of equivalent volume followed by a continuous intravenous infusion of NaCl 0.9% administered up to 6 hours after surgery. |
| Intervention |
Tranexamic acid |
The administration of tranexamic acid/placebo will start following the induction of general anesthesia. Bolus dose of 30 mg/kg of tranexamic acid followed by a continuous intravenous infusion of 16 mg/kg/h of tranexamic acid administered up to 6 hours after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Patients aged 18 to 65 years
• Patients undergoing spinal surgery with expected significant blood loss
• Physical status ASA I to III inclusive
|
|
| ExclusionCriteria |
| Details |
• Allergy to tranexamic acid
• Epilepsy
• Minimally invasive surgery
• Unwillingness to receive blood transfusion
• Known coagulopathy/hepatic disease
• Previous thromboembolic events
• Pregnancy
• Renal impairment
• Colour blindness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Measures
•% of patient transfusions
•Number of transfusions
Secondary Measures
•Measured blood losses
•Morbidity
|
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measured blood losses
oMorbidity
oMortality
oLength of stay in the hospital
oCalculated blood losses
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2012 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal surgery may be associated with substantial blood loss which often requires erythrocyte transfusion. Transfusion of RBCs is not free of adverse events and has been associated with increased risks of infection, and globally higher morbidity and mortality.Different techniques have been used to reduce perioperative blood losses and related transfusions. Tranexamic acid has been used successfully in cardiac, Joint replacement and hepatic surgery.However, only a few studies have reported on the use of antifibrinolytic drugs in spinal surgery.This study is designed to assess the efficacy and safety of tranexamic acid in spinal surgery for the reduction of RBC transfusion |