Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01258010
First received: December 8, 2010
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Neurosurgery
Orthopedic Surgery
Red Blood Cell Transfusion
Drug: Tranexamic Acid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Percentage of patients transfusions [ Time Frame: From surgery until 72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Number of red blood cell transfusions [ Time Frame: From surgery until 72 hours postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measured blood losses [ Time Frame: From surgery until 72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Morbidity [ Time Frame: From surgery until 30 days postoperatively ] [ Designated as safety issue: Yes ]
    Deep vein thrombosis, pulmonary embolism, seizures, myocardial infarction, renal failure

  • Mortality [ Time Frame: From surgery until 30 days postoperatively ] [ Designated as safety issue: Yes ]
  • Length of stay in the hospital [ Time Frame: At time of discharge ] [ Designated as safety issue: No ]
  • Calculated blood losses [ Time Frame: From surgery until 72 hours postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 99
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258010

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Jean-François Hardy, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01258010     History of Changes
Other Study ID Numbers: JFH2011-001
Study First Received: December 8, 2010
Last Updated: April 30, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Red blood cell transfusion
Neurosurgery
Orthopedic surgery
Tranexamic acid
Surgical blood loss

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014