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Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery

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ClinicalTrials.gov Identifier: NCT04058665
Recruitment Status : Active, not recruiting
First Posted : August 15, 2019
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.

Condition or disease Intervention/treatment
Blood Loss Device: Floseal

Detailed Description:

Blood loss is a major concern in spine surgery. Within lumbar fusion surgery, one study estimated an average blood loss of 800 mL (range 100-3,100 mL) for non-instrumented fusion and 1,517 mL (range 360-7,000 mL) for instrumented fusions. Blood transfusions are required in an estimated 8% to 36% of patients undergoing spine surgery.Transfusion promotes tissue perfusion and oxygen delivery during extensive surgeries, yet carries with it rare but significant risks. These include acute lung injury, febrile reactions, allergic episodes, infection, and impaired immune response. Given these potential risks, strategies to minimize extensive blood loss and resultant transfusion are warranted.

Previously described approaches in the literature that can minimize blood loss during spine surgery include: hypotensive anesthesia, hemostatic agents (e.g. FloSeal®), antifibrinolytic medications, advanced bipolar cautery (e.g. Aquamantys®), autologous blood salvage (e.g. Cell Saver®), perioperative and intraoperative temperature, operative time, nutritional state, coagulopathy, restrictive transfusion triggers, and rotational thromboelastometry (ROTEM).

Researchers in several medical fields have attempted to delineate comprehensive anemia prevention strategies described as "blood-saving bundles". A bundle encapsulates multiple evidence-based interventions that result in improved patient outcomes-here with a focus on reduced blood loss-when combined versus when each intervention is used in isolation. Care bundles applied to intensive care unit treatment and pneumonia, sepsis, and acute kidney injury care have demonstrated improved clinical outcomes. However, no bundled protocol currently exists that aim to decrease blood loss and transfusion incidence during spine surgery. Moreover, no data exist that identify whether use of FloSeal® over other hemostatic agents as part of a bundled protocol results in decreased blood loss and transfusion rates, improved surgical outcomes, and improved cost effectiveness.

Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.

This retrospective multivariate analysis will identify potential factors associated with increased blood loss and transfusion incidence. The investigators anticipate using these findings to develop a future bundled protocol for implementation in all patients undergoing spine surgery at Johns Hopkins Hospital after approval by the Institutional Review Board. Such a bundled protocol has the potential to improve surgical outcomes and decrease institutional costs.

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Observational group
No intervention performed. This is the overall group that will be retrospectively assessed for different variables pertaining to blood loss.
Device: Floseal
Hemostatic agent




Primary Outcome Measures :
  1. Total blood loss [ Time Frame: 1 week ]
    Cubic centimeters (cm^3) of blood loss throughout the operation.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Up to 1 month ]
    Days spent over entire hospital stay.

  2. Number of postoperative infections [ Time Frame: Up to 3 months ]
    All types of infection will be collected (surgical site infection, pneumonia, etc.)

  3. Number of transfusion complications [ Time Frame: Up to 1 month ]
    All possible transfusion complications

  4. Number of medical complications [ Time Frame: Up to 1 month ]
    Overall number of patient infections and transfusion complications.

  5. Overall cost of care during time in hospital [ Time Frame: Up to 1 year ]
    Total cost (dollars).

  6. Operating room cost [ Time Frame: Up to 1 year ]
    Cost (dollars) of the actual operation.

  7. Total length of hospital stay cost [ Time Frame: Up to 1 year ]
    Cost (dollars) included in the overall hospital stay.

  8. Transfusion cost [ Time Frame: Up to 1 year ]
    Cost (dollars) for the amount of transfusions the patient required.

  9. Hospital disposition after surgery [ Time Frame: Up to 1 month ]
    Postoperatively placed in the intensive care unit versus regular hospital floor.

  10. Discharge disposition after surgery [ Time Frame: Up to 1 month ]
    Discharged home versus discharged to a rehab facility.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing lumbar spine surgery at Johns Hopkins Hospital
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Undergoing lumbar spine surgery
  • Surgery performed between July 1, 2016 and November 30, 2018
  • Surgery performed at the Johns Hopkins East Baltimore Campus
  • Available data on hemostatic agents used

Exclusion Criteria:

  • Age under 18
  • Surgery at location other than lumbar spine
  • Surgical details unavailable
  • Data unavailable for specified endpoints, including:

    • Hemostatic agent use
    • Blood loss
    • Operative time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058665


Locations
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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Daniel M Sciubba, MD Johns Hopkins University
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04058665    
Other Study ID Numbers: IRB00200167
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
Lumbar spine surgery
Blood loss
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes