Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Capital Medical University

Status: Enrolling

Conditions: Intraoperative Blood Loss; Meningioma; Tranexamic Acid

Treatments: Drug: Placebo; Drug: Continous infusion; Drug: Single infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05230381

2022018

Details and patient eligibility

About

Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter >5cm on brain image.
• Age between 18-65 years.
• American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
• Obtain written informed consent.

Exclusion criteria

• Allergic to tranexamic acid.
• History of thrombotic disease.
• History of chronic kidney disease
• Receiving other anticoagulation or antiplatelet treatment.
• Refuse to provide written informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 3 patient groups, including a placebo group

Continous infusion group

Active Comparator group

Description:

Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.

Treatment:

Drug: Continous infusion

Single infusion group

Active Comparator group

Description:

Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.

Treatment:

Drug: Single infusion

Placebo group

Placebo Comparator group

Description:

Infusion with same volume of 0.9% saline.

Treatment:

Drug: Placebo