Randomized control trial to determine the effectiveness of transfusion of patients own blood in patient undergoing scoliosis surgery.

Phase 3

• Conditions: Health Condition 1: M411- Juvenile and adolescent idiopathicscoliosis

• Registration Number: CTRI/2020/10/028519
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Elective surgery for correction of scoliosis.

2.Age group: 11 - 18 years.

3.Patient with expected blood loss of at least 1000 ml or ï?³ 15 ml/kg.

4.Haemoglobin >=11g/dl.

5.Both Male and Female patients.

Exclusion Criteria

1.Haemoglobin <11g/dl.

2.Cardiac disorders (E.g. cyanotic heart disease)

3.Significant pulmonary disease (E.g. obstructive pulmonary disease)

4.Renal disorder (E.g. chronic kidney disease)

5.Uncontrolled hypertension

6.Coagulation and bleeding disorder (PT >1.5 times normal value & Platelet count <100000/µl)

7.Haematological disorders with regular transfusion therapy

8.Presence of bacteraemia &/or sepsis

9.Revision surgery

10.Patient undergoing spinal surgery above T1 level.

11.Pregnancy

12.Patient transfused with blood components in 1 month prior to surgery.

13.Syndromic scoliosis

14.Neuromuscular scoliosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of allogenic blood component transfused in both the intraoperative and postoperative phases until 48hrs after surgery in both group of patients.Timepoint: Upto 48hrs after surgery

Secondary Outcome Measures

Name	Time	Method
1.Safety of the ANH by assessment of laboratory parameters like Haemoglobin, Haematocrit, Platelet count, prothrombin time (PT) & Activated partial thromboplastin time (aPTT) and Renal function test prior to surgery, 24 & 48 hours post operatively and at the time of discharge. <br/ ><br>2.Total volume of post-operative blood loss in ml/kg till 48 hours. <br/ ><br>3.Direct cost involved during the ANH procedure and current transfusion practices <br/ ><br>Timepoint: 1 Before surgery, 24hr & 48hr after surgery