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Completed

NCT Number: NCT04595786

The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.

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Key information

Conditions

Seizures Central Nervous System Neoplasms Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) age 18-80 years
  • 2) American Society of Anesthesiologist (ASA) classification score I~III

Exclusion criteria

  • 1) allergic to tranexamic acid
  • 2) preoperative seizures
  • 3) history of thrombotic disease
  • 4) chronic kidney disease
  • 5) breastfeeding or pregnancy
  • 6) refuse to participate in the study

Treatment and study plan

Tranexamic Acid

Drug

20mg/kg TXA was prepared in a 50ml syringe for intravenous pump

0.9% saline

Drug

0.9% saline was prepared in a 50ml syringe for intravenous pump

Primary outcomes

  1. Early postoperative seizures within 7 days

    Time frame: Within 7 days after surgery

    Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.

Secondary outcomes

  1. The incidence of non-epileptic complications

    Time frame: Within 7 days after the intervention

    Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.

  2. Estimated intraoperative blood loss

    Time frame: During surgery

    Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).

  3. The changes in haemoglobin concentrations

    Time frame: During surgery

    The changes in haemoglobin concentrations between baseline and end of surgery.

  4. The intraoperative blood transfusion volume and rate

    Time frame: During surgery

    The intraoperative blood transfusion volume and rate.

  5. The intraoperative cell saver volume and rate

    Time frame: During surgery

    The intraoperative cell saver volume and rate.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Acronym: STAMP

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2020
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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