ScoliosisNCT03814239
Blood and Fluid Management During Scoliosis Surgery
An observational study of Scoliosis, run by George Papanicolaou Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scoliosis
- What is being tested?
- protocol
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteGreece
- Study dates
- 30 Oct 2011to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled for elective orthopaedic surgery of scoliosis, with a planned intensive care unit admission, were enrolled in a retrospective observational study.
Who may be able to join
- severe curve (Cobb Angle > 70-degree)
- same surgeon in all procedures
Who cannot join
- Patients with coagulopathy,
- morbid obesity
- severe cardiopulmonary disease
- liver dysfunction
- renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood and Fluid Management During Scoliosis Surgery: A Single Center Retrospective Analysis
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.
Read the detailed description
At investigators institution, neither anesthetic approaches to replacement of blood or fluid losses were standardized before 2014 for scoliosis surgery. Before 2014, fluid therapy was liberal and according to general principles of good clinical practice and ephedrine boluses of 5 mg were given when fluid boluses failed to maintain a systolic arterial pressure >90 mm Hg. Blood was replaced with crystalloid at a 3:1 ratio and colloid at a 1:1 ratio. Regarding blood product transfusion anesthesiologists were generally initiated when hemoglobin levels were less than 8 g/dl or less than 10 g/dl in patients with coronary diseases and predonated autologous or allogeneic RBCs were administered.
A protocol of management for scoliosis surgery was implemented in 2014 and included: a) fluid therapy according to SVV monitor, b) intraoperative permissive hypotension to reduce active bleeding (goal mean arterial pressure 60 mmHg), c) prophylactic tranexamic acid infusion (30 mg/kg bolus, 1mg/kg/hr during surgery), d) restrictive RBC trigger according to national standardized protocols (Hb<7.0 g/dL or <9g/dL in patients with coronary diseases) and e) use of perioperative cell savage.
In patients of Group Pro, 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.
Data will be collected from anesthesia records and included: age, gender, height, weight, body mass index and ASA score. Additional variables included infused crystalloid volume, infused colloid volume and the number of allogeneic transfused units of RBC. Serum Hb levels were measured preoperatively and after the end of surgery. Moreover, diuresis and use of vasopressors use were recorded.
- Conditions
- Scoliosis
- Being tested
- protocol
- Keywords
- transfusion, goal directed fluid therapy
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| no protocol | liberal fluid therapy | |
| protocol | fluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver Receives: Other: protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Secondary outcomes (4)
volume of crystalloids infused
the overall volume of crystalloids infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
Measured: intraoperative
volume of colloids infused
the overall volume of colloid infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h. If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
Measured: intraoperative
infused vasopressors
The decision to use ephedrine or noradrenaline. In patients of Group Pro if after two consecutive fluid boluses SVV remained >15%, administration of noradrenaline or ephedrine was considered.
Measured: intraoperative
diuresis
volume of urine production during surgery.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start30 Oct 2011
- Primary completion20 Nov 2016
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stachtari Chrysoula MD, PhD, George Papanicolaou Hospital
- Investigators
- Anastasia Trikoupi, Study chair, Director of Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814239
- Sponsor's protocol ID
- papskoliosis
- Status last verified
- Jan 2019
- First submitted
- 20 Jan 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32016528
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Fluid Management During Scoliosis Surgery: A Single Center Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03814239
- Acronym / sponsor ID
- papskoliosis
- Conditions
- Scoliosis
- Keywords
- transfusion, goal directed fluid therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- 30 Oct 2011 (actual)
- Primary completion
- 20 Nov 2016 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At investigators institution, neither anesthetic approaches to replacement of blood or fluid losses were standardized before 2014 for scoliosis surgery. Before 2014, fluid therapy was liberal and according to general principles of good clinical practice and ephedrine boluses of 5 mg were given when fluid boluses failed to maintain a systolic arterial pressure >90 mm Hg. Blood was replaced with crystalloid at a 3:1 ratio and colloid at a 1:1 ratio. Regarding blood product transfusion anesthesiologists were generally initiated when hemoglobin levels were less than 8 g/dl or less than 10 g/dl in patients with coronary diseases and predonated autologous or allogeneic RBCs were administered.
A protocol of management for scoliosis surgery was implemented in 2014 and included: a) fluid therapy according to SVV monitor, b) intraoperative permissive hypotension to reduce active bleeding (goal mean arterial pressure 60 mmHg), c) prophylactic tranexamic acid infusion (30 mg/kg bolus, 1mg/kg/hr during surgery), d) restrictive RBC trigger according to national standardized protocols (Hb<7.0 g/dL or <9g/dL in patients with coronary diseases) and e) use of perioperative cell savage.
In patients of Group Pro, 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.
Data will be collected from anesthesia records and included: age, gender, height, weight, body mass index and ASA score. Additional variables included infused crystalloid volume, infused colloid volume and the number of allogeneic transfused units of RBC. Serum Hb levels were measured preoperatively and after the end of surgery. Moreover, diuresis and use of vasopressors use were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no protocol | – | –liberal fluid therapy |
| protocol | – | Other: protocolfluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for elective orthopaedic surgery of scoliosis, with a planned intensive care unit admission, were enrolled in a retrospective observational study.
Key inclusion criteria (2 listed)
- severe curve (Cobb Angle > 70-degree)
- same surgeon in all procedures
Key exclusion criteria (5 listed)
- Patients with coagulopathy,
- morbid obesity
- severe cardiopulmonary disease
- liver dysfunction
- renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protocolIn 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. | Other | protocol |
Primary outcome
units of red blood cells transfused
Time frame: intraoperative
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.
4 secondary outcomes
volume of crystalloids infused
Time frame: intraoperative
volume of colloids infused
Time frame: intraoperative
infused vasopressors
Time frame: intraoperative
diuresis
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 32016528Koraki 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Trikoupi study chair
Director of Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by George Papanicolaou Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
units of red blood cells transfused (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.