| CTRI Number |
CTRI/2024/05/066769 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A scientific clinical trial to study the effect of medicine namely Tranexamic Acid versus normal saline in reducing blood loss during brain surgery among patients diagnosed with brain tumours. |
|
Scientific Title of Study
|
Effect of Tranexamic acid on the reduction of blood loss in Neuro Oncosurgical patients A Randomized control study
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Asiel Christopher |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Basavatarakam IndoAmerican Cancer Hospital and Research Institute |
| Address |
Department of OncoAnaesthesiology Pain and Palliative Medicine
Operation theatre Complex
Block 1
Fourth Floor
Banjara Hills
Road No 10
Nandi Nagar
Hyderabad
Telangana State
India
Road No 10
Nandi Nagar
Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9441242029 |
| Fax |
|
| Email |
asiel.chris08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Raja |
| Designation |
Fellow OncoAnaesthesiology Pain and Palliative Medicine |
| Affiliation |
Basavatarakam IndoAmerican Cancer Hospital and Research Institute |
| Address |
Department of OncoAnaesthesiology Pain and Palliative Medicine
Operation theatre Complex
Block 1
Fourth Floor
Banjara Hills
Road No 10
Nandi Nagar
Hyderabad
Telangana State
India
Road No 10
Nandi Nagar
Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9442212993 |
| Fax |
|
| Email |
capsjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Asiel Christopher |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Basavatarakam IndoAmerican Cancer Hospital and Research Institute |
| Address |
Department of OncoAnaesthesiology Pain and Palliative Medicine
Operation theatre Complex
Block 1
Fourth Floor
Banjara Hills
Road No 10
Nandi Nagar
Hyderabad
Telangana State
India
Road No 10
Nandi Nagar
Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9441242029 |
| Fax |
|
| Email |
asiel.chris08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of OncoAnaesthesiology Pain and Palliative Medicine
Operation theatre Complex
Block 1
Fourth Floor
Basavatarakam IndoAmerican Cancer Hospital and Research Institute
Banjara Hills
Road No 10
Nandi Nagar
Hyderabad 500034
Telangana State
India |
|
|
Primary Sponsor
|
| Name |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of OncoAnaesthesiology Pain and Palliative Medicine
Operation theatre Complex
Block 1
Fourth Floor
Banjara Hills
Road No 10
Nandi Nagar
Hyderabad 500034
Telangana State
India |
| 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 |
| M Asiel Christopher |
Basavatarakam IndoAmerican Cancer hospital and research Institute |
Department of OncoAnaesthesiology Pain and Palliative Medicine
Operation theatre Complex
Block 1
Fourth Floor
Banjara Hills
Road No 10
Nandi Nagar
Hyderabad 500034
Telangana State
India
Hyderabad
TELANGANA |
9441242029
asiel.chris08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee BIACHRI |
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 |
| Comparator Agent |
Using Normal saline in comparator group in place of tranexamic acid |
Normal Saline 150ml bolus loading dose given intravenous over 20 minutes followed by normal saline 2.5ml per hour intravenous infusion till the completion of surgery |
| Intervention |
Using Tranexamic acid in study group to study the reduction in blood loss in patients with supratentorial brain tumour undergoing Craniotomy and decompression |
Injection Tranexamic acid 20mg per kg intravenous bolus loading dose followed by 1mg per kg per hour intravenous infusion till the completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18-65 years with the diagnosis of a Supratentorial brain tumour planned for undergoing Craniotomy and decompression are to be recruited |
|
| ExclusionCriteria |
| Details |
1. Allergy to tranexamic acid
2. Known Arterial or venous Thromboembolism
3. Known Coagulopathy- Altered PT, INR, aPTT
4. Use of Antiplatelet therapy or antocoagulant therapy
5. Significant Kidney (CKD 3-5) or Liver Disease (Child Pugh B, C).
6. Pregnant and Lactating Mothers
7. Patient Refusal to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Blood Loss |
1. Blood loss during surgery is measured by the anaestheiologist .
2. Post operative hemoglobin and hematocrit will be measured on post operative day 2 and 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Inraoperative surgical site assessment and Surgeons satisfaction.
2. Reduction in blood transfusion
3. Development of Deep vein Thrombosis |
1. Intraoperative surgical site assessment, surgeons satisfaction and documentation of Boezaart score.
2.PT,INR will be measured on Post operative day 1.
3. Preoperative and post opeartive day 5 and 30 for Deep Vein Thrombosis screening will be done.
4. The indication, quantity and time of blood transfusion will be documented |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
14/05/2024 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [asiel.chris08@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
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Brief Summary
|
Tranexamic acid (TXA) is a anti fibrinolytic agent that has been shown to reduce bleeding and blood transfusions in a variety of surgical disciplines. In neuro-onco-surgeries, significant blood loss requiring blood transfusion can occur in the perioperative period. However, there are few studies evaluating the use and challenges of Tranexamic acid in neuro-onco-surgeries, where significant blood loss can occur and perioperative thromboprophylaxis can be challenging. In this study we assess the effect of tranexamic acid in the reduction of blood loss. We also attempt to assess the need for blood transfusions, incidence of deep vein thrombosis and surgeon’s satisfaction about intraoperative bleeding. Significance of study: This study will assess the effect of tranexamic acid in reducing blood loss and blood transfusion, and development of deep vein thrombosis in oncological patients undergoing neurosurgery. This will help in reducing the blood transfusion requirements and load in the blood bank in our hospital.
Methodology For all patients, pre anaesthetic checkup will be done as per department protocol. Patients with demographic data, namely age, weight, height, details of the size and type of tumour from the CT scan are collected. On the day of surgery, haemoglobin will be collected. Screening of deep vein thrombosis will be done by one of the primary investigators with Colour Doppler imaging and compression ultrasound to assess proximal and distal lower limb veins in pre op holding area. Before induction, patients will be randomised by computer generated numbers into two groups Group A Patients receiving Tranexamic acid 20 mg per kg actual body weight (diluted in 50 ml Normal saline at 150 ml/hour) over 20 minutes + 1 mg/kg/hour (20 mg per kg of Tranexamic acid diluted in 50 ml of Normal saline at 2.5 ml per hour) infused till the completion of surgery. Group B Patients receiving saline 150 ml per hour for 20 minutes + 2.5 ml per hour infusion till the completion of surgery.
Intraoperatively, arterial blood gases will be done at the discretion of the anaesthesiologist. Blood loss will be estimated based on collection in the suction bottle and soakage of mops and pads by the anaesthesiologist who will be unaware of the treatment group of the patient. . Blood will be transfused if Hb< 8 gm%, in cardiac patients if haemoglobin is between 8 to 10 g%, otherwise unexplained tachycardia or high vasopressor support. The use of Abgel and surgicel will be noted. At the end of the surgery, the satisfaction of the surgeon will be evaluated and documented by the Boezaart score for intraoperative surgical field. Post operative haemoglobin and haematocrit will be measured on post operative day 2 and 5. In ICU, mechanical thromboprophylaxis will be provided to all patients. No low molecular weight heparin will be administered as per hospital policy. Screening for deep vein thrombosis as done in the pre operative period will be done on day 5 and 1 month after surgery by the primary investigator who will be blinded to the allocation of the patient. Length of hospital stay will also be documented. Neurological improvement will be assessed based on the Glasgow outcome scale on post operative day 5 and post operative day 30. Any other complications occurring during hospital stay will be documented.
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