A comparative study between International normalized Ratio (INR) guided versus clinical discretion guided blood component replacement therapy in patients undergoing major surgery

Abstract

Bleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP), is often life saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. The aim of the present study was to evaluate and compare the usage of INR guided vs clinician discretion based component replacement therapy which will optimize the use of FFP and may even result in less blood loss during surgery. Materials and Method: This study was conducted in surgical patients in a large tertiary care centre. Ethical clearance was taken from the local ethics committee at the proposal stage itself. Patients consent was taken after providing all necessary information prior to surgery. This study was conducted on 200 patients. The groups were randomised to two groups of Gp 1- study(S) -100 patients (point of care based transfusion management) Gp 2- control (C)- 100 patients (physician discretion based management). After premedication with intravenous morphine (0.05- 0.1 mg/kg body weight), Glycopyrrolate and ondansetron, General anaesthesia was induced with thiopentone sodium. Endotracheal intubation Intubation achieved after vecuronium. Anesthesia was maintained using low flow nitrous oxide: oxygen mixture (fresh gas flow of 1ltr each) and Isoflurane (1 MAC) via a closed circuit cycle absorber system and mechanical ventilation with 5 – 10 ml/kg. Standard monitoring will include HR, ECG (two lead), blood pressure (NIBP/ IABP), SpO2, Naso pharyngeal temperature. Patient warming was done with warm air blower (with a target temp above 360C). In the control group physician discretion was used to guide Blood platelet or FFP transfusion based on the institutional protocol. These are blood if Hb <8 gm %, platelets if <50,000 or between 50,000-80,000 with ongoing blood loss and FFP if bleeding >20% or >2 units blood given and repeated if physician desires. However these are guidelines and physician discretion based on clinical judgment is freely allowed. In the test group if bleeding is estimated to be more than 205 CBC and POC INR is done. If Hb < 8 gm % blood is transfused, if platelets <50,000 then 1 Single Donor Platelets or 6 Random Donor Platelets are transfused. 2 units of FFP are transfused if POC INR >1.8. Test was repeated after 30mins and 2 more units of FFP was given if INR >1.5. Result: there was no difference in age distribution sex weight of pateints between the two group, however the need for blood component therapy was in higher in pateints who were treated based on clinical discretion compared to INR guided treatment. The mean duration of post-operative ventilation required for the patient to be extubated with stable haemodynamic parameters in the test group was 48.55 hrs compared to 78.4 hrs for the control group. The maximum duration of post-operative ventilation in test group was 212 hrs, compared to 281 hrs for the control group. While the minimum duration was comparable being 18 hrs for test group and 19 hrs for control group. One-Sample Kolmogorov-Smirnov Test was done in each group to ensure normal distribution due to wide distribution of data.From our study we concluded that when INR guided blood component therapy was done the need for blood products was much lesser and the need for post-operative mechanical ventilation was much lesser in inr guided group compared to clinical discretion based therapy.