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Effect of Fibrinogen given before surgery on surgical Bleeding among patients undergoing surgery for Brain tumor

Effect of Fibrinogen Prophylaxis on Perioperative Bleeding in patients with Cerebral Meningioma undergoing elective Craniotomy: A Double-Blind Placebo-Controlled Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/046046
Enrollment
80
Registered
2022-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Fibrinogen prophylaxis: Patients will receive a single prophylactic dose of 2 gm of fibrinogen in 100 ml of 0.9% normal saline infusion through an intravenous route over one hour Contro

Sponsors

Post Graduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years 2. ASA- I and II 3. Patients with cerebral meningioma undergoing elective craniotomy surgery

Exclusion criteria

Exclusion criteria: 1. Patientââ?¬•s refusal to participate in the study 2. Patients allergic to fibrinogen 3. Patients planned for preoperative embolization 4. Patients with deranged liver function test or pre-existing liver disease and congestive heart failure 5. Patients with bleeding diathesis, deranged coagulation profile or previous thromboembolic complication 6. History of renal impairment 7. Pregnant or lactating patients

Design outcomes

Primary

MeasureTime frame
To evaluate the perioperative blood loss (including intraoperative and 48 hours postoperative period) among patients undergoing craniotomy for cerebral meningioma.Timepoint: Intraoperative and 48 hours postoperative period—

Secondary

MeasureTime frame
I. Plasma levels of fibrinogen, hemoglobin (Hb), hematocrit(HCT), prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) and suction drain volume at 0, 6, and 24 hours. II. Number of blood products (packed red blood cell, fresh frozen plasma and platelet) transfused. III. Intraoperative crystalloid and colloid used. IV. Brain relaxation score and surgeon satisfaction score. V. Surgical time and anaesthesia time (in minutes). VI. Other vital parameters like heart rate (HR), mean arterial pressure (MAP), pulse oximetry (SPO2), end-tidal carbon dioxide (ETCO2), central venous pressure (CVP) and urine output (UO). VII. Any perioperative complications. VIII. ICU and hospital stay (in days). IX. Modified Rankin Scale (MRS) at discharge. X. Extended Glasgow Outcome Scale (GOSE) at 3 months. Timepoint: Intraoperative, 48 hours postoperative period and up to 3 months after surgery.—

Countries

India

Contacts

Public ContactDr Amiya Kumar Barik

Post Graduate Institute of Medical Education and Research, Chandigarh

amiyabarik.scb@gmail.com08052919523

Outcome results

None listed

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