Status:
COMPLETED
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
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Hospital Vall d'Hebron
Hospital Clinic of Barcelona
Conditions:
Spinal Fusion
Antifibrinolytic Agents
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01136590
Start Date
September 1 2010
End Date
May 1 2014
Last Update
February 24 2015
Active Locations (4)
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1
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08029
2
Hospital Vall d'Hebron de Barcelona
Barcelona, Barcelona, Spain, 08035
3
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
4
Hospital de Getafe
Getafe, Madrid, Spain