NCT01258010

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

December 8, 2010

Last Update Submit

April 30, 2014

Conditions

NeurosurgeryOrthopedic SurgeryRed Blood Cell Transfusion

Keywords

Red blood cell transfusionNeurosurgeryOrthopedic surgeryTranexamic acidSurgical blood loss

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients transfusions

    From surgery until 72 hours postoperatively

  • Number of red blood cell transfusions

    From surgery until 72 hours postoperatively

Secondary Outcomes (5)

  • Measured blood losses

    From surgery until 72 hours postoperatively

  • Morbidity

    From surgery until 30 days postoperatively

  • Mortality

    From surgery until 30 days postoperatively

  • Length of stay in the hospital

    At time of discharge

  • Calculated blood losses

    From surgery until 72 hours postoperatively

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Tranexamic acid
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.

Normal saline (NaCl 0.9%)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Allergy to tranexamic acid
  • Epilepsy
  • Minimally invasive surgery
  • Unwillingness to receive blood transfusion
  • Known coagulopathy/hepatic disease
  • Previous thromboembolic events
  • Pregnancy
  • Renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jean-François Hardy, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 10, 2010

Study Start

April 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

CA(1)