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topical tranexamic acid in perioperative blood loss of the posterior lumbar spinal surgery

Phase 3
Recruiting
Conditions
Condition 1: ???? ???? ???. Condition 2: ?????? ???? ??? ???? ???? ?????.
Other intervertebral disc displacement, lumbar region
Unspecified fracture of unspecified lumbar vertebra, initial encounter for closed fracture
M51.26
S32.009A
Registration Number
IRCT20200203046351N1
Lead Sponsor
Bagheiat-allah University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
104
Inclusion Criteria

Patients with age between 18 to 75 years .
Patients whom needs posterior lumbar spinal surgery
Traumatic patients ( in the first 3 weeks after injury)
Non-traumatic patients (with maximum 4 spinal level envolved)

Exclusion Criteria

History of thromboembolism
Emergent surgery with indications other than neurosurgical indications
Treatment with other drugs that affect blood coagulation such as sodium valproate
Any transexamic acid intake before (eg polymenorrhea in women or in dentistry)
Treatment with anticoagulants
Treatment with antiplatelets
Spinal penetrating injury
Hemodynamical unstability
History of epilepsy or seizure
Liver malfunction
Renal failure
Abnormal results of laboratory coagulation tests
Patient's reluctance

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intraoperative blood loss. Timepoint: At the end of the operation. Method of measurement: with use of standard anesthesia chart by ml.
Secondary Outcome Measures
NameTimeMethod
Duration of hospitalization. Timepoint: Time of discharge. Method of measurement: Questionnaire.;Coagulation studies. Timepoint: At the beginning of the study and post op. Method of measurement: questionnaire.;Duration of returning to work. Timepoint: 2 month post op. Method of measurement: questionnaire.
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