Blood and Fluid Management During Scoliosis Surgery

NCT03814239 | Completed DMC

• 1 other identifier: papskoliosis
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

In the present retrospective study, it was hypothesized that application, in scoliosis surgery, of a protocol for blood and fluid management, based on goal directed fluid therapy, cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells transfusion. The patients will be enrolled in a retrospective observational study and divided in two groups. Patients in no protocol Group received a liberal intraoperative fluid therapy and patients in protocol Group received fluid therapy managed according to a stroke volume variation based protocol. The protocol included fluid therapy according to SVV monitor, permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of perioperative cell savage.

Conditions

Scoliosis

Keywords

transfusion; goal directed fluid therapy

Outcome Measures

Primary Outcomes (1)

• units of red blood cells transfused

  the overall units of red blood cells transfused during surgery. Hb\< 7 was the trigger for transfusion in protocol group and Hb\<8 for no transfusion group.

  intraoperative

Secondary Outcomes (4)

• volume of crystalloids infused

  intraoperative

• volume of colloids infused

  intraoperative

• infused vasopressors

  intraoperative

• diuresis

  intraoperative

Study Arms (2)

no protocol

liberal fluid therapy

protocol

fluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver

Other: protocol

Interventions

protocol OTHER

In patients of Group Protocol , basal crystalloid infusion was started at 4 ml/kg/h right after general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop, Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously and noninvasively through finger- cuffed technology. If SVV was \>15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After two consecutive fluid boluses SVV remained \>15%, administration of noradrenaline infusion was considered.

protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective orthopaedic surgery of scoliosis, with a planned intensive care unit admission, were enrolled in a retrospective observational study.

You may qualify if:

• severe curve (Cobb Angle \> 70-degree)
• same surgeon in all procedures

You may not qualify if:

• Patients with coagulopathy,
• morbid obesity
• severe cardiopulmonary disease
• liver dysfunction
• renal disease

Sponsors & Collaborators

• George Papanicolaou Hospital: lead

Study Sites (1)

George Papanikoalou Hospital

Thessaloniki, 57010, Greece

Location

Related Publications (1)

• Koraki E, Stachtari C, Stergiouda Z, Stamatopoulou M, Gkiouliava A, Sifaki F, Chatzopoulos S, Trikoupi A. Blood and fluid management during scoliosis surgery: a single-center retrospective analysis. Eur J Orthop Surg Traumatol. 2020 Jul;30(5):809-814. doi: 10.1007/s00590-020-02637-y. Epub 2020 Feb 3.

  PMID: 32016528 DERIVED

MeSH Terms

Conditions

Scoliosis

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Anastasia Trikoupi

  Director of Anesthesiology Department

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou hospital

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 23, 2019
• Study Start: October 30, 2011
• Primary Completion: November 20, 2016
• Study Completion: January 1, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-01

Locations

GR (1)