- NAME OF THE CANDIDATE:
Anil Kumar B.N.
#404, 6th main, Near ISEC,
Teachers Colony, Nagarbhavi,
Bangalore -560072
- NAME OF THE INSTITUTION:
St. John’s Medical College,
SarjapurRoad,Bangalore -560034
3. COURSE OF STUDY AND SUBJECT
M.D. Anaesthesiology
4. DATE OF ADMISSION TO THE COURSE
16th April 2012
5.TITLE OF THE TOPIC
Effect of TRANEXAMIC ACID on blood loss and transfusion requirements in lumbar spine fixation surgery
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for study
Lumbar spine fixation surgery is associated with substantial blood loss and may require multiple blood transfusions and transfusion of other blood components which subject the patient to inherent risks of transfusion namely, acquired infections, immune modulatory effects of allogenic blood. This has led to the investigation of haemostatic agents such as TRANEXAMIC ACID in reducing the blood loss and hence transfusion requirements.
TRANEXAMIC ACID is a synthetic antifibrinolytic drug that competitively blocks lysine binding sites on plasminogen molecules and inhibits plasmin formation thereby retarding fibrinolysis and blood clot degradation. TRANEXAMIC ACID is being increasingly used in orthopaedic surgery, but the efficacy in reducing blood loss in controversial. Therefore this study attempts to re-evaluate the efficacy of TRANEXAMIC ACID in lumbar spine fixation surgery.
6.2 Review of literature
Investigations carried out by DAVID.T NEILIPOVITZ et al in 2001, on 40 patients aged 9-18 years with either primary or secondary scoliosis in which 10 mg per kg TRANEXAMIC ACID or placebo was administered over 15 minutes after positioning the patient. A maintenance infusion of 1mg/kg per hour of TRANEXAMIC ACID or placebo was initiated on completion of the initial dose and was continued until skin closure. They concluded that TRANEXAMIC ACID has the potential to reduce the peri operative transfusion requirements in paediatric patients undergoing posterior spine fusion for Scoliosis.
A study carried out by P.N. KALKAR et al on efficacy and safety of TRANEXAMIC ACID in control of bleeding following total knee replacement in 2009 in which patients were allocated into four groups consisting of fifty patients in total.
- Unilateral TKR patients receiving TRANEXAMIC ACID (12)
- Bilateral TKR patients receiving TRANEXAMIC ACID (13)
- Unilateral TKR patients receiving normal saline (12)
- Bilateral TKR patients receiving normal saline (13)
Patients receiving Tranexamic acid at 10mg/kg i.v. followed by an infusion of 1mg/kg/ hour or an equivalent volume of Physiological saline at the end of which they concluded that Tranexamic acid reduces the peri operative bleeding by almost half in patients undergoing TKR.
A study carried out by PURSHOTHAM LAL GAUTHAM et al on effect of Tranexamic acid on blood loss and transfusion requirements in total knee replacements in Indian Populations in 2011- Study comprised of Forty patients who were randomly allocated into control groups and Tranexamic acid groups and Twenty patients received Tranexamic acid at 10mg/kg/ i.v approximately half an hour before deflation of tourniquet and three hours after first dose, while the other twenty received normal saline. They concluded that Tranexamic acid results in significant reduction in blood loss and the amount of blood transfusion required in patients undergoing TKR.
Study carried out by NAVIL.S.F.SETHNA et al on effect of Tranexamic Acid in reducing intra operative blood loss in pediatric patients undergoing scoliosis surgery. Forty four patients scheduled to undergo elective spinal fusion were randomly assigned to receive either 100mg /kg Tranexamic acid before incision followed by infusion of 10mg/kg/hr during surgery or 0.9% saline. They concluded that blood loss was reduced by 41% in patients who received Tranexamic Acid compared to Saline.
Study carried out by FARROKHI.M.R. et al on efficacy of low dose of prophylactic tranexamic acid in lumbar spine fixation surgery. Seventy Six patients were selected, Thirty Eight patients received Tranexamic Acid (10mg/kg) at induction of anaesthesia followed by i.v. infusion of 1mg/kg/hr of Tranexamic Acid and Thirty Eight patients received normal saline. They concluded that prophylactic low dose of Tranexamic Acid does not have any effect in the management of intra operative blood loss over transfusion requirements in patients undergoing spine fixation surgery
6.3 Objectives of this study
To evaluate the efficacy of Tranexamic Acid on blood loss and the need for blood transfusion in the lumbar spine fixation surgery.
7. MATERIAL AND METHODS :
7.1 Source of the Data
The study will be carried out in St. Johns Medical College and Hospital over a period of two years.
Inclusion criteria
a) Adult patient in the age group of 30-60 undergoing two or more than two levels of lumbar spine fixation surgery.
b) Patients with American Society of Anaesthesiologists ( ASA) physical status of I-III.
Exclusion criteria:
a)Pre existing renal or hepatic disorder
b)Bleeding diathesis and abnormal PT,APTT or platelet counts
c)History of malignancy or coronary artery defect
d)Thrombo-embolic event one year prior to surgery
e)Acute infection
f)Current use of anti-platelet medication or anti-coagulants
g)Haemoglobin less than 8gm/dl
7.2Method of collection of the data
This will be a double blinded prospective randomised placebo controlled study of thirty patients in each group. The patients will be randomly allocated into tranexamic acid group and the placebo or control group. The study design will be such that the surgeon, anaesthesiologist and the investigator collecting the data will be blinded as to which the solution that is being administered.
The details of the study along with the purpose and nature will be explained to the patient in the language best understood by patient and written informed consent will be taken prior to the surgery. The study will be carried out in a controlled environment under expert’s supervision.
Out of the sixty patients, thirty patients will receive tranexamic acid – 10mg/kg over fifteen minutes after the induction of general anaesthesia and thirty patients will receive normal saline(control or placebo group) followed by an infusion of1mg/kg per hour of tranexamic acid or an equivalent volume of normal saline upto to the closure of the wound.
Outcome measures will include total intraoperative blood loss, amount of intra operative blood transfusion, pre-operative and post-operative haemoglobin and haematocrit, and pre-operative and post-operative PT and APTT. The details collected will be kept confidential and the data collected will be analysed using appropriate statistical method. The data will not be used for any purpose other than the study mentioned above.
8. LIST OF REFERENCES:
a) NavilF.Setha, David Zurakowski, Robert M.Brustowicz :Tranexamic Acid Reduces Intra operative Blood Loss in Pediatric Patients Undergoing Scoliosis Surgery. 2005;102:727-32.
b) David T. Neilpovitz, KimmoMurto, Leslie Hall : A randomized trial of Tranexamic acid to reduce blood transfusion for scoliosis surgery. (AnaesthAnalg 2001; 93: 82-7)
c) Kazemi AP, Farrokhi MR, EftekharinHR : Efficacy prophylactic low dose of tranexamicacid in spinal fixation surgery : A randomized clinical trial. 2011 Oct : 23(4) : 290-6.
d) PurshothamLalGautha, Sunil katyal : effect of tranexamic acid on blood loss and transfusion and requirement in total knee replacement in Indian Population : a case series. 2011 Nov-Dec; 55(6) : 590-593.
e) Akay MH, Senay S, Karabulut H, Toraman F, AlhamHC : Low-dose tranexamic acid use in isolated coronary artery bypass surgery. 2012 Sep;94(3): 1037-8.
9.ETHICAL CLEARANCE: YES
10.Signature of the candidate
11.Remarks of the guide:
Tranexamic acid has been used in cardiac surgery,orthopaedic surgery and other major surgeries to reduce blood loss.This study will help us to determine if tranexamic acid is effective in reducing blood loss in lumbar spine fixation surgery.
12.NAME AND DESIGNATION OF THE:
12.I GUIDE: Dr LATHA.P.JOHN
PROFESSOR
12.2 SIGNATURE:
12.3 HEAD OF DEPARTMENT: Dr VASUDEVA UPADHYAYA K.S
12.4 SIGNATURE:
13.
13.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL:
13.2 SIGNATURE:
Rajiv Gandhi University of Health Sciences
Karnataka, Bangalore
Annexure 2
Proforma for registration of subjects for dissertation