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A clinical trial to evaluate the procedure of taking patient own blood just before the start of surgery and giving it back to the patient at the end in Brain operations.

Acute Normovolemic Hemodilution in Intracranial Meningiomas, Arteriovenous Malformations and High Grade Vascular Brain Tumor Surgeries - A Prospective Randomized Controlled Study - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025965
Enrollment
108
Registered
2020-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: D320- Benign neoplasm of cerebral meninges Health Condition 2: Q079- Congenital malformation of nervoussystem, unspecified Health Condition 3: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Acute Normovolemic Hemodilution (ANH): Two units of blood will be withdrawn from the patient just prior to surgery and will be re-transfused to patient towards the end of surgery Contr

Sponsors

Dr Manbir Kaur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with American Society of Anaesthesiologist (ASA) grade 1 and grade 2 2. Patients of either sex 3. Age 18 years and above 4. Patients with haemoglobin greater than 11 g/dl 5. Patients with intracranial meningiomas and other high grade vascular tumors/ vascular malformations with estimated blood loss greater than 500 ml - 1 litre.

Exclusion criteria

Exclusion criteria: 1. Patients with haemoglobin less than 11 g/dl 2. Patients with impaired renal or hepatic function 3. Pregnant women 4. Patients with deranged coagulation profile 5. Patients with coagulation disorders or patients on anticoagulants 6. Patients with a history of ischemic heart diseases, history of myocardial infarction, or patients with fixed cardiac output states.

Design outcomes

Primary

MeasureTime frame
The primary objective is to evaluate the difference between hemoglobin and hematocrit parameters in both the groups.Timepoint: intraoperatively, at the end of surgery and postoperatively—

Secondary

MeasureTime frame
1) Perioperative hemodynamics in both the groups. 2) Perioperative blood loss in both the groups. 3) Perioperative need for allogenic blood transfusion in both the groups. 4) Perioperative platelet count and coagulation parameters in both groups. 5) Perioperative arterial blood gases in both groups. 6) Perioperative complications in each group. 7) Overall ICU stay and Length of hospital stay in each group. Timepoint: intraoperatively, at the end of surgery and postoperatively—

Countries

India

Contacts

Public ContactDr Manbir Kaur

All India Institute of Medical Sciences Jodhpur

doctor.manbir@gmail.com8557086389

Outcome results

None listed

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