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The Effect of Tranexamic acid and Intra-abdominal Pressure on Intraoperative Blood Loss in Lumbar Laminectomy

The Effect of Tranexamic acid and Intra-abdominal Pressure on Intraoperative Blood Loss in Lumbar Laminectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138708021388N1
Enrollment
102
Registered
2009-01-23
Start date
2008-12-21
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

bleeding during lumbar laminectomy. T81.0

Interventions

Intervention 1: injection of normal saline 0.1ml/kg before the incision and then 0.1ml/kg/h. Intervention 2: injection of tranexamic acid 10mg/kg before the incision and then 1mg/kg/h.
Placebo
Prevention
injection of normal saline 0.1ml/kg before the incision and then 0.1ml/kg/h
injection of tranexamic acid 10mg/kg before the incision and then 1mg/kg/h

Sponsors

Vice-Chancellor for reaserch , Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: candidates for elective lumbar lamiectomy aged between 15 up to 65. Exclusion criteria: history of renal, hepatic, and cardiac diseases, impaired PT and PTT, aspirin usage in previous two weeks, taking OCP, history of CVA, hypertension, morbid obesity.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean volume of bleeding. Timepoint: all the time of operation. Method of measurement: to measure the volume of suctioned blood and weigh the collected gauze from the field.;Mean intra-abdominal pressure. Timepoint: before the incision in supine position and after pronation. Method of measurement: to measure intra-vesical pressure by Foley catheter and CVP ruler.;Mean of MAPs during the operation. Timepoint: every 5 minutes. Method of measurement: digital NIBP.

Secondary

MeasureTime frame
Mean volume of bleeding according to operated segments. Timepoint: all the time of operation. Method of measurement: to maesure the suctioned blood and weigh the collected gauze from the field.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Anoush Dehnadi Moghadam

Guilan University of Medical Sciences

info@gtrc.ir+98 13 1323 8373

Outcome results

None listed

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