| CTRI Number |
CTRI/2018/08/015421 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
17/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Tranexamic acid in reducing blood loss in total hip replacement surgeries |
|
Scientific Title of Study
|
Efficacy & Safety of two treatment regimens of Tranexamic Acid in blood sparing effect in Primary unilateral Total Hip Arthroplasties: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subrata Kumar Singha |
| Designation |
Additional Professor |
| Affiliation |
Department of Anaesthesia |
| Address |
Room No:2, Block A, Gate No: 4, AIIMS,
PO: Tatibandh,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subrata Kumar Singha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
Room No:2, Block A, Gate No: 4, AIIMS,
PO: Tatibandh,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subrata Kumar Singha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
Room No:2, Block A, Gate No: 4, AIIMS,
PO: Tatibandh,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Project, Internal funding by All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
PO: Tatibandh,
Raipur - 492099,
Chhattisgarh |
| 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 |
| Dr Subrata Kumar Singha |
AIIMS, Raipur |
Room No2, Faculty room, Block A, Gate No 4,
AIIMS,
PO: Tatibandh,
Raipur - 492099
Raipur
CHHATTISGARH |
8518881767
subratsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECR/714/Inst/CT/2015 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M249||Joint derangement, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group (Placebo) versus Tranexamic acid |
Control group -No drug is administered
Group 1 - Tranexamic acid is administered at a decided dose as per protocol which is 15 mg/kg
Group 2 - Tranexamic acid at 15 mg/kg before skin incision and a second dose 6 hours after the first dose at a dose of 15 mg/kg |
| Intervention |
NO intervention apart from comparing the placebo group versus a single dose of the drug versus a double dose of tranexamic acid. |
Group 1 - 15 mg/kg of TXA in 100 ml of NS administered over a period of 10 minutes before skin incision
Group 2 - 15 mg/kg of TXA in 100 ml of NS administered over a period of 10 minutes before skin incision + 15 mg/kg IV TXA 6 hours after intravenous dose
Group 3 - Control group (No intervention)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients, 18 – 65 years of either sex with ASA grade I and II undergoing primary elective unilateral hip joint arthroplasty by same surgeon. |
|
| ExclusionCriteria |
| Details |
Patients with
a) The absence of written informed consent
b) Bilateral arthroplasties
c) Complicated primary total hip arthroplasty with previous osteotomy, simultaneous fracture fixation, implant removal or bone grafting,
History of thromboembolic diseases,
d) The presence of clotting disorder or current treatment with an antiplatelet agent, anticoagulant or deep vein thrombosis (DVT) prophylaxis in the perioperative period,
e) Renal disease
f) History of the previous allergy to TXA.
g) History of labile or uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Drop in Hct after 24 hours
b. Blood transfusion requirement in the first 24 hours |
Pre-op Hb/Hct:
Post-op Hb/Hct:
Immediately after surgery:
24 hours after surgery:
48 hours after surgery:
Drain output:
3 hours after surgery:
6 hours after surgery:
12 hours after surgery:
24 hours after surgery:
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
c. Decrease in inflammatory markers (IL6 and D-dimer) after 12 hours compared to the baseline
d. Complications if any during the stay in hospital
|
The Quantitative value of IL6: Before the start of surgery and 12 hours after surgery:
The Quantitative value of D-dimer: Before the start of surgery and 12 hours after surgery:
|
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
24/08/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled blinded trial comparing the efficacy and safety of single dose IV tranexamic acid in one arm comprising of 63 subjects in each arm) with that of IV plus single postoperative IV dose of tranexamic acid with regards to drop in hematocrit after 24 hours, requirement of blood transfusion after 24 hours as the primary outcome in our institution over a period of one year. The secondary outcomes of the study will include a possible decrease in inflammatory markers like IL 6 & D-Dimer after 12 hours, the length of hospital stay and complications if any in the hospital. |