- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258010
Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Administration of study drug
The administration of tranexamic acid/placebo will start following the induction of general anesthesia. A bolus dose will be given intravenously over 30 minutes followed by a continuous infusion administered up to 6 hours postoperatively.
Drugs used for anesthesia and postoperative analgesia will be left to the discretion of the attending anesthesiologist. The administration of fluids (crystalloids, colloids and blood products) will be recorded.
Transfusion: The transfusion trigger will be < 80 g/L during surgery if the situation is stable. Transfusion may be initiated according to the attending anesthesiologist if the situation is unstable. In the case of massive bleeding, transfusion will follow our standard institutional protocol. The presence of microvascular bleeding at the surgical site will be assessed by the surgeon. The Cellsaver will not be used.
The transfusion trigger during the postoperative period will be < 80 g/L. Blood losses and the need for transfusion will be recorded from the moment of surgery up to 72 hours postoperatively.
Laboratory testing
Before surgery: hemoglobin and coagulogram values will be recorded.
During surgery: the patient's coagulation status will be assessed using a thromboelastograph (TEG). Thromboelastography is a simple coagulation test that enables evaluation of all components of hemostasis. TEG testing will be performed at the induction of anesthesia and every 2 hours throughout surgery. An additional blood sample for TEG analysis will be collected at the end of surgery if the previous test was performed more than an hour before the end of surgery.
After surgery: laboratory testing for hemoglobin, coagulogram, fibrinogen and d-dimer will be performed in the recovery room. Hemoglobin will also be measured on postoperative days 1, 2 and 3. Blood samples to assess cardiac troponin levels will be collected on postoperative days 1 and 2.
Ultrasound : Patients will have an ultrasound examination of the inferior limbs before discharge from the hospital to detect deep vein thrombosis.
Follow-up The presence of adverse events during the course of the hospital stay will be noted.
At 30 days, patients will be contacted by phone to detect any other adverse events.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 18 to 85 years
- Patients undergoing spinal surgery with expected significant blood loss
- American Society of Anesthesiologists physical status(ASA) I to III inclusive
Exclusion Criteria:
- Allergy to tranexamic acid
- Epilepsy
- Minimally invasive surgery
- Unwillingness to receive blood transfusion
- Known coagulopathy/hepatic disease
- Previous thromboembolic events
- Pregnancy
- Renal impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic acid
Study subjects will be randomized to receive a bolus dose of 30 mg/kg of tranexamic acid administered over 30 minutes starting after the induction of anesthesia followed by a continuous intravenous infusion of tranexamic acid of 16 mg/kg/h administered up to 6 hours after surgery.
|
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 Comparator: Normal saline (NaCl 0.9%)
Study subjects will be randomized to receive a bolus dose of normal saline (NaCl 0.9%) of equivalent volume administered over 30 minutes starting after the induction of anesthesia followed by a continuous intravenous infusion of NaCl 0.9% administered up to 6 hours after surgery.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of red blood cell transfusions
Time Frame: From surgery until 72 hours postoperatively
|
From surgery until 72 hours postoperatively
|
Percentage of patients transfusions
Time Frame: From surgery until 72 hours postoperatively
|
From surgery until 72 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measured blood losses
Time Frame: From surgery until 72 hours postoperatively
|
From surgery until 72 hours postoperatively
|
|
Morbidity
Time Frame: From surgery until 30 days postoperatively
|
Deep vein thrombosis, pulmonary embolism, seizures, myocardial infarction, renal failure
|
From surgery until 30 days postoperatively
|
Mortality
Time Frame: From surgery until 30 days postoperatively
|
From surgery until 30 days postoperatively
|
|
Length of stay in the hospital
Time Frame: At time of discharge
|
At time of discharge
|
|
Calculated blood losses
Time Frame: From surgery until 72 hours postoperatively
|
From surgery until 72 hours postoperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-François Hardy, MD, FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JFH2011-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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