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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

Primary Purpose

Spinal Fusion, Antifibrinolytic Agents, Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tranexamic Acid
fisiologic serum
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fusion focused on measuring Spinal deformity correction, Surgical bleeding, Transfusion practice, Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Bellvitge
  • Hospital de Getafe
  • Hospital Clinic de Barcelona
  • Hospital Vall d'Hebron de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tranexamic acid

placebo

Arm Description

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

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)

Outcomes

Primary Outcome Measures

The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period

Secondary Outcome Measures

Total blood loss: intraoperative and postoperative values
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
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

Full Information

First Posted
June 2, 2010
Last Updated
February 23, 2015
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital Universitario Getafe
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1. Study Identification

Unique Protocol Identification Number
NCT01136590
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital Universitario Getafe

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion
Keywords
Spinal deformity correction, Surgical bleeding, Transfusion practice, Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid
Arm Type
Experimental
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
fisiologic serum
Intervention Description
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)
Primary Outcome Measure Information:
Title
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
Time Frame
7 days postoperative period
Secondary Outcome Measure Information:
Title
Total blood loss: intraoperative and postoperative values
Description
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.
Time Frame
48 hours postoperative
Title
Adverse events in the perioperative period, immediate postoperative period, and at mid-term
Description
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
Time Frame
up to 6 weeks after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria J Colomina, MD Ph
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Misericordia Basora, MD Ph
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maylin Koo, MD Ph
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Pizones, MD
Organizational Affiliation
Hospital de Getafe.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Hospital de Getafe
City
Getafe
State/Province
Madrid
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
Hospital Vall d'Hebron de Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28203735
Citation
Colomina MJ, Koo M, Basora M, Pizones J, Mora L, Bago J. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trialdagger. Br J Anaesth. 2017 Mar 1;118(3):380-390. doi: 10.1093/bja/aew434.
Results Reference
derived

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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

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