NeurosurgeryNCT01258010
Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery
A study testing Tranexamic Acid in people with Neurosurgery and Orthopedic Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurosurgery, Orthopedic Surgery, Red Blood Cell Transfusion
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to tranexamic acid
- Epilepsy
- Minimally invasive surgery
- Unwillingness to receive blood transfusion
- Known coagulopathy/hepatic disease
- Previous thromboembolic events
- Pregnancy
- Renal impairment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Neurosurgery, Orthopedic Surgery, Red Blood Cell Transfusion
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Red blood cell transfusion, Neurosurgery, Orthopedic surgery, Tranexamic acid, Surgical blood loss
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | 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. Receives: Drug: Tranexamic Acid |
| Normal saline (NaCl 0.9%) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients transfusions
Measured: From surgery until 72 hours postoperatively
Number of red blood cell transfusions
Measured: From surgery until 72 hours postoperatively
Secondary outcomes (5)
Measured blood losses
Measured: From surgery until 72 hours postoperatively
Morbidity
Deep vein thrombosis, pulmonary embolism, seizures, myocardial infarction, renal failure
Measured: From surgery until 30 days postoperatively
Mortality
Measured: From surgery until 30 days postoperatively
Length of stay in the hospital
Measured: At time of discharge
Calculated blood losses
Measured: From surgery until 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Hardy, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258010
- Sponsor's protocol ID
- JFH2011-001
- Status last verified
- Apr 2014
- First submitted
- 8 Dec 2010
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery
- ClinicalTrials.gov ID
- NCT01258010
- Acronym / sponsor ID
- JFH2011-001
- Conditions
- Neurosurgery, Orthopedic Surgery, Red Blood Cell Transfusion
- Keywords
- Red blood cell transfusion, Neurosurgery, Orthopedic surgery, Tranexamic acid, Surgical blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidStudy 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. |
| Normal saline (NaCl 0.9%) | Placebo comparator | Drug: PlaceboStudy 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Allergy to tranexamic acid
- Epilepsy
- Minimally invasive surgery
- Unwillingness to receive blood transfusion
- Known coagulopathy/hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidBolus 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. | Drug | Tranexamic acid |
| PlaceboBolus 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. | Drug | Normal saline (NaCl 0.9%) |
Primary outcome
Percentage of patients transfusions
Time frame: From surgery until 72 hours postoperatively
Number of red blood cell transfusions
Time frame: From surgery until 72 hours postoperatively
5 secondary outcomes
Measured blood losses
Time frame: From surgery until 72 hours postoperatively
Morbidity
Time frame: From surgery until 30 days postoperatively
Mortality
Time frame: From surgery until 30 days postoperatively
Length of stay in the hospital
Time frame: At time of discharge
Calculated blood losses
Time frame: From surgery until 72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Hardy, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Neurosurgery and Orthopedic Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients transfusions (time frame: From surgery until 72 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.