| CTRI Number |
CTRI/2025/02/080224 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Viscoelastic point of care test of Thromboelastography] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Thromboelastography (device used to test for blood clot formation and lysis) versus conventional treatment on need of drugs (which promote clot formation) and need of blood products during elective complex spine surgery- a randomized study. |
|
Scientific Title of Study
|
Effect of Thromboelastography® Guided versus Conventional Haemostatic Therapy on Intraoperative Antifibrinolytic and Transfusion requirement in Elective complex spine surgeries- A Randomized, Parallel Arm study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunaina Tejpal Karna |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
09540946869 |
| Fax |
|
| Email |
drtejpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rehan Ul Haq |
| Designation |
Professor and Head |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Orthopedics, AIIMS Bhopal, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7982360432 |
| Fax |
|
| Email |
rehan.ortho@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sunaina Tejpal Karna |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
09540946869 |
| Fax |
|
| Email |
drtejpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| DHR-ICMR Young Medical Faculty Ph.D. research Grant,
Department of Health Research, 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi, India- 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Sunaina Tejpal Karna |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal- 462020. |
| Type of Sponsor |
Other [DHR-ICMR Ph.D. Young Medical Faculty Grant ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Jai Prakash Sharma |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal- 462020. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunaina Tejpal Karna |
All India Institute of Medical Sciences Bhopal |
Department of Anesthesiology, 3rd Floor, Trauma Block, Main Hospital Building, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH |
09540946869
drtejpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Bhopal Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Hemostatic therapy |
A standard 15 mg/kg dose of Tranexamic acid will be given after anesthetic induction and securing of endotracheal tube.
Hemostatic practices will be based on routine strategy in our institute. Transfusion of other blood components will be based on either laboratory values of
1. International Normalized Ratio (INR) more than 1.5- FFP 10-15 ml/kg
2. Platelet count less than 80000/cumm- 4 RDP/1 SDP
3. Plasma Fibrinogen level less than 1.5gm/L- Cryoprecipitate will be given.
If laboratory coagulation values are not promptly obtained, empirical hemostatic product transfusion will be based on signs of bleeding, the patient’s hemodynamic status, and the consultant anesthesiologist’s judgment.
|
| Intervention |
Thromboelastography guided hemostatic therapy. |
Baseline Thromboelastography (TEG) will be done at time of securing intravenous cannula in preoperative room. TEG will be done every two hours or earlier if needed as per blood loss to see the coagulation hemostasis till skin closure. TEG-guided Hemostatic therapy will be done based on the percentage of clot lysis (Ly 30) in TEG to decide the Tranexamic acid dose.
1. Severe fibrinolysis (Ly30 is more than 7.5 percent)- 15 mg/kg
2. Moderate fibrinolysis (Ly 30 between 3-7.5 percent)- Tranexamic acid 10 mg/kg
3. Physiological fibrinolysis (Ly 30 between 0.8-2.9 percent)- No tranexamic acid.
4. Fibrinolysis shutdown (lY30 less than 0.8 percent)- No tranexamic acid
Transfusion of blood products will be as follows
1.If alpha angle is less than 50 degrees- Cryoprecipitate transfusion 15-30mg/kg
2. If Reaction time (R) is more than 8 min- Fresh Frozen Plasma (FFP) 10 ml/kg
3. If Maximum amplitude (MA) less than 50 mm- 4 Random donor Platelets (RDP) or 1 Single Donor Platelets (SDP).
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adolescent and adult patients
American Society of Anesthesiologists (ASA) Physical status I-III classification
BMI less than 35Kg per msquare
Undergoing instrumented spine surgery of thoracic or lumbar spine (between T1 and S1) by a posterior midline approach
Providing informed consent to participate in the surgery. |
|
| ExclusionCriteria |
| Details |
History of allergy or hypersensitivity to Tranexamic acid.
History of frequent bleeding, past or family history of thromboembolism (stroke, Non-fatal myocardial infarction, pulmonary embolism, bowel infarction)
Current treatment with anticoagulants other than aspirin
Laboratory values of Hemoglobin less than 10gm/dl, Serum creatinine more than 1.5 mg per dl, Platelet count less than 1.5 lakhs per cumm, International Normalized Ratio (INR) more than1.4, activated partial thromboplastin time more than 38 s.
Patients with a neoplastic, infectious spinal condition or polytrauma.
Minimally invasive spine surgery like endoscopic discectomy.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total dose of tranexamic acid- mg per kg
Weighted average Tranexamic acid given per kg per hour during surgery. |
During surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total number and type of blood products transfused in intervention versus comparator group |
first 24 hours, first week of surgery |
| Incidence of hypercoagulability assessed by TEG parameters, IncidencE OF Thromboembolic events and average Wells score for Deep venous thrombosis and Pulmonary Embolism |
First week after surgery |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
· This randomized parallel arm study (1:1 allocation, total sample size 172) will be done in the Orthopedic/ Neurosurgery Modular operation theatre complex and wards at All India Institute of Medical Sciences Bhopal. After ethical committee approval and clinical trial registration, participants will be recruited as per the specified inclusion and exclusion criteria. Stratified block randomization with varying block size according to surgical extent (less than or more than 4 segments will be done into either Thromboelastography guided (T) or Conventional (C) intraoperative haemostatic treatment groups, with 86 participants each, with the use of an opaque serially numbered sealed envelope technique for allocation concealment. Baseline Thromboelastography will be done on all study participants. The transfusion trigger will be 8gm/dl during surgery. Standard anesthetic and fluid management will be done during surgery. Intraoperative management will be as follows: TEG Guided Treatment (Group T)- Thromboelastography two hourly or earlier to assess coagulation hemostasis. Tranexamic acid dose and blood product transfusion will be based on the percentage of clot lysis (Ly 30) and other TEG parameters. Conventional Hemostatic therapy (Group (C) - Standard 15 mg/kg dose of Tranexamic acid after anesthetic induction. Hemostatic practices will be based on the routine strategy based on signs of bleeding, the patient’s hemodynamic status, and clinical judgment. Follow-up: A blinded study investigator will assess the total dose of Tranexamic acid during surgery, transfusion of blood products on day of surgery and till 71 week after surgeryt. Follow up will be done daily in the first postoperative week for venous thromboembolism (VTE) using the Wells score and findings of hypercoagulability on TEG on the first, third, fifth, and seventh postoperative days. • Expected outcome- TEG-based hemostatic therapy will generate evidence for the optimal dose of Tranexamic acid required in elective complex spine surgery and may prevent unnecessary transfusion and postoperative VTE in the first seven postoperative days. |