Clinical Trials Logo

Clinical Trial 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 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01136590
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact
Status Completed
Phase Phase 4
Start date September 2010
Completion date May 2014

See also
  Status Clinical Trial Phase
Completed NCT02815670 - Reversal Dabigatran Anticoagulant Effect With Idarucizumab Phase 3
Completed NCT04588350 - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery N/A
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02554006 - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings N/A
Completed NCT02569606 - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT01955720 - Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran Phase 1
Completed NCT01935427 - Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume N/A
Recruiting NCT01709786 - Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage N/A
Completed NCT01191554 - Dose-ranging Study of Tranexamic Acid in Valve Surgery N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01085006 - The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery Phase 1/Phase 2
Completed NCT00700141 - Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil® N/A
Completed NCT00375466 - Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery. N/A
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00147420 - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet N/A
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Completed NCT03273322 - Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure Phase 2/Phase 3
Withdrawn NCT05672407 - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery Phase 4
Not yet recruiting NCT05464394 - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass Phase 3