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Evaluation of Therapeutic Effect of Tranexamic Acid Infusion on Intraparenchymal Hemorrhage

Evaluation of therapeutic effect of Tranexamic Acid infusion on reducing blood loss during neurosurgery in Traumatic Brain injury patients with intraparenchymal hemorrhage

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016031427051N1
Enrollment
40
Registered
2016-09-04
Start date
2016-05-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Intracranial injury. Focal brain injury

Interventions

Intervention 1: The intervention group will receive a package containing four vials of 500 mg TXA and two sterile syringe size 21.The drug is administered as a loading dose ( 1g TXA added to 100 ml o
Treatment - Drugs
The intervention group will receive a package containing four vials of 500 mg TXA and two sterile syringe size 21.The drug is administered as a loading dose ( 1g TXA added to 100 ml of 0.9% normal sa
The control group will receive a package containing four vials of 500 mg placebo and two sterile syringe size 21.The drug is administered as a loading dose ( 1g Normalsaline added to 100 ml of 0.9% no

Sponsors

Vice challenge for research of Ahvaz Jondishapour University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria : age over 18 years old; attendance to the emergency room within the first 8 hours of the accident; trauma to the head with Intraparenchymal hemorrhage (IPH) on brain CT scan; absence of significant extra-cranial hemorrhage such as intra-abdominal hemorrhage; absence of fracture or deformity of limbs; absence of subarachnoid hemorrhage; absence of hematuria; absence of known coagulopathy; necessity to perform neurosurgery in clinical evaluation and according to neurosurgeon's opinion. Exclusion criteria :Existence of pregnancy; the presence of other types of intracranial hemorrhage other than intraparenchymal hematoma; need to FFP or massive whole blood transfusion; hematuria; presence of subarachnoid hemorrhage; usage of anticoagulant drugs and aspirin.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Amount of bleeding during surgery. Timepoint: during surgery. Method of measurement: Suctioned blood volume measurement.

Secondary

MeasureTime frame
Duration of hospitalization. Timepoint: After surgery. Method of measurement: according to patient's documents.;Result of functional Test. Timepoint: 28 days after surgery or at time of discharge. Method of measurement: Examinations conducted by researcher.;Duration of surgery. Timepoint: At time of surgery. Method of measurement: Document of patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Mozafari

Ahvaz Jundishapour University of Medical Sciences

Mozafari.taha@yahoo.com+98 61 3374 3079

Outcome results

None listed

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