Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Hospital Universitario Getafe
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01136590
First received: June 2, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery.

OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period.

METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.


Condition Intervention Phase
Spinal Fusion
Antifibrinolytic Agents
Hemorrhage
Blood Transfusion
Drug: Tranexamic Acid
Drug: fisiologic serum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period [ Time Frame: 7 days postoperative period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total blood loss: intraoperative and postoperative values [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
    Intraoperative blood loss is evaluated by measuring the volume of suction aspirate and weighing the swabs with a precision digital scale. Postoperative blood loss is determined by recording the volume of blood collected through the suction drains at 24 and 48 hours.

  • Adverse events in the perioperative period, immediate postoperative period, and at mid-term [ Time Frame: up to 6 weeks after the procedure ] [ Designated as safety issue: Yes ]
    Adverse events in the perioperative period, immediate postoperative period, and at mid-term (up to 6 weeks after the procedure) will be recorded, with special emphasis on follow-up of thrombotic events and clinically suspected deep venous thrombosis, renal function, and visual abnormalities reported by the patient


Estimated Enrollment: 130
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tranexamic acid
tranexamic acid will be administered as a bolus (10-mg/kg dose ) or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery
Drug: Tranexamic Acid
A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.
Placebo Comparator: placebo
The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)
Drug: fisiologic serum
The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥18 years old of both sexes
  • scheduled for complex spine surgery
  • ASA I-III
  • weighing more than 30 kg
  • body mass index <30 kg/m2
  • operated on in the participating hospitals
  • major spinal surgery
  • signed an informed consent form to be included in the study

Exclusion Criteria:

  • a history of allergy or hypersensitivity to the agent used
  • receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
  • a history of frequent bleeding
  • plasma creatinine values >1.5 mg/dL in the baseline analysis
  • platelet count less than 150,000/mm3 in the follow-up analysis
  • abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5)
  • a history of a thromboembolic episode before surgery
  • family history of thromboembolism
  • lack of consent to participate in the study
  • infectious disease, tumor or trauma of the spine as the reason for surgery
  • scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day
  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: NCT01136590

Contacts
Contact: Maria J Colomina, MD +34934893504 ext 4863 mjcolomina@gmail.com
Contact: Inmaculada Fuentes, MD + 34934894113 ext 4881 inma.fuentes@vhir.org

Locations
Spain
Hospital de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain
Contact: Maylin Koo, MD Ph         
Principal Investigator: Maylin Koo, MD Ph         
Hospital de Getafe Recruiting
Getafe, Madrid, Spain
Contact: Javier Pizones, MD         
Principal Investigator: Javier Pizones, MD         
Hospital Vall d'Hebron de Barcelona Recruiting
Barcelona, Spain, 08035
Contact: Maria J Colomina, MD Ph    + 34934893504 ext 4863    mjcolomina@gmail.com   
Contact: Inmaculada Fuentes, MD    + 34932746000 ext 4881    inma.fuentes@vhir.org   
Principal Investigator: Maria J Colomina, MD         
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08029
Contact: Misericordia Basora, MD Ph         
Principal Investigator: Misericordia Basora, MD Ph         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Hospital Vall d'Hebron
Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Hospital Universitario Getafe
Investigators
Study Chair: Maria J Colomina, MD Ph Hospital Vall d'Hebron
Principal Investigator: Misericordia Basora, MD Ph Hospital Clinic of Barcelona
Principal Investigator: Maylin Koo, MD Ph Hospital Universitari de Bellvitge
Principal Investigator: Javier Pizones, MD Hospital de Getafe
  More Information

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01136590     History of Changes
Other Study ID Numbers: TRANEX2009, 2008-006938-94
Study First Received: June 2, 2010
Last Updated: March 31, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Spinal deformity correction
Surgical bleeding
Transfusion practice
Spinal Fusion
Antifibrinolytic Agents
Hemorrhage
Blood Transfusion

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
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 September 18, 2014