Comparing two different doses of a medicine which reduces blood loss (tranexamic acid), on its effect on total blood loss and blood product transfusion requirements in patients undergoing surgery for removing tumors located at base of brain

Comparing two doses of intraoperative tranexamic acid on blood loss, blood and blood product transfusion requirements in patients undergoing complex skull base tumour resection: A non-inferiority randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094625

Enrollment

140

Registered

2025-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Low Dose Tranexamic Acid: Tranexamic acid administration at 10 mg/kg bolus followed by 1mg/kg/hr infusion from incision time till start of dural closure Control Intervention1: Intermedi

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I-III, undergoing craniotomies for excision of complex skull base tumours

Exclusion criteria

Exclusion criteria: Extremes of age less than 18 and more than 70 years, ASA IV, Patients with known allergy to the drug, Patients with a past history of Deep Vein Thrombosis, CVT or pulmonary embolism, Stroke any increased risk for thrombosis, Patients with IHD on a coronary stent, post CABG, low EF, Patients with motor deficit, Polycythaemia ? Haemoglobin more than 17 gms, Pre-operative Haemoglobin less than 8 gms, Pre-operative transfusion less than 1 week, Patients with CKD with creatinine more than 1.5 mgs, Patients with uncontrolled seizures, Pre-existing coagulopathy, Bleeding disorders

Design outcomes

Primary

Measure	Time frame
Blood loss and blood, blood product transfusion requirementsTimepoint: Incision time to 6 hours after surgery	—

Secondary

Measure	Time frame
Serum tranexamic acid concentrationTimepoint: One hour;Rotational thromboelastometry parametersTimepoint: One hour;Incidence of complications associated with TXA administration, such as seizure & Deep venous thrombosis (DVT) or pulmonary embolism (PE)Timepoint: One week	—

Countries

India

Contacts

Public ContactSreekumar M R

Christian Medical College

ramamani@cmcvellore.ac.in9443753184

Outcome results

None listed

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