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

Randomized controlled trial to determine the effectiveness of Acute Normovolemic Haemodilution (ANH) for perioperative blood management in patients undergoing scoliosis surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028519

Enrollment

Registered

2020-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M411- Juvenile and adolescent idiopathicscoliosis

Interventions

Intervention1: Acute Normovolemic Haemodilution: ANH will be initiated immediately after the induction of anaesthesia. Blood will be collected using the 350 ml standard blood bags, containing CPD as t

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Haemoglobin 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 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 2. Total volume of post-operative blood loss in ml/kg till 48 hours. 3. Direct cost involved during the ANH procedure and current transfusion practices Timepoint: 1 Before surgery, 24hr & 48hr after surgery	—

Measure

Time frame

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. 2. Total volume of post-operative blood loss in ml/kg till 48 hours. 3. Direct cost involved during the ANH procedure and current transfusion practices Timepoint: 1 Before surgery, 24hr & 48hr after surgery

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Countries

India

Contacts

Public ContactBasanta Khatiwada

All India Institute of Medical Sciences

drrahulchaurasia@gmail.com9560345917

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026