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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01258010
Other study ID # JFH2011-001
Secondary ID
Status Completed
Phase N/A
First received December 8, 2010
Last updated April 30, 2014
Start date April 2011
Est. completion date April 2014

Study information

Verified date April 2014
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Spinal surgery may be associated with substantial blood loss which often requires erythrocyte transfusion. Transfusion of red blood cells (RBC) is not free of adverse events and has been associated with increased risks of infection, and globally higher morbidity and mortality.

Different techniques have been used to reduce perioperative blood losses and related transfusions. Tranexamic acid has been used successfully in cardiac and hepatic surgery. However, only a few studies have reported on the use of antifibrinolytic drugs in spinal surgery.

This study was designed to assess the efficacy and safety of tranexamic acid in spinal surgery for the reduction of RBC transfusion.

Hypothesis: the infusion of tranexamic acid during spinal surgery will reduce the risk of receiving a RBC transfusion and, in those patients transfused, reduce the number of blood products administered.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Tranexamic Acid
Bolus dose of 30 mg/kg of tranexamic acid followed by a continuous intravenous infusion of 16 mg/kg/h of tranexamic acid administered up to 6 hours after surgery.
Placebo
Bolus dose of normal saline (NaCl 0.9%) of equivalent volume followed by a continuous intravenous infusion of NaCl 0.9% administered up to 6 hours after surgery.

Locations

Country Name City State
Canada Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients transfusions From surgery until 72 hours postoperatively Yes
Primary Number of red blood cell transfusions From surgery until 72 hours postoperatively Yes
Secondary Measured blood losses From surgery until 72 hours postoperatively Yes
Secondary Morbidity Deep vein thrombosis, pulmonary embolism, seizures, myocardial infarction, renal failure From surgery until 30 days postoperatively Yes
Secondary Mortality From surgery until 30 days postoperatively Yes
Secondary Length of stay in the hospital At time of discharge No
Secondary Calculated blood losses From surgery until 72 hours postoperatively Yes
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