Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing lumbar spine surgery at Johns Hopkins Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss	Cubic centimeters (cm^3) of blood loss throughout the operation.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Days spent over entire hospital stay.	Up to 1 month
Number of postoperative infections	All types of infection will be collected (surgical site infection, pneumonia, etc.)	Up to 3 months
Number of transfusion complications	All possible transfusion complications	Up to 1 month
Number of medical complications	Overall number of patient infections and transfusion complications.	Up to 1 month
Overall cost of care during time in hospital	Total cost (dollars).	Up to 1 year
Operating room cost	Cost (dollars) of the actual operation.	Up to 1 year
Total length of hospital stay cost	Cost (dollars) included in the overall hospital stay.	Up to 1 year
Transfusion cost	Cost (dollars) for the amount of transfusions the patient required.	Up to 1 year
Hospital disposition after surgery	Postoperatively placed in the intensive care unit versus regular hospital floor.	Up to 1 month
Discharge disposition after surgery	Discharged home versus discharged to a rehab facility.	Up to 1 month

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Daniel M Sciubba, MD, Johns Hopkins University

Publications and helpful links

General Publications

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• Kuduvalli M, Oo AY, Newall N, Grayson AD, Jackson M, Desmond MJ, Fabri BM, Rashid A. Effect of peri-operative red blood cell transfusion on 30-day and 1-year mortality following coronary artery bypass surgery. Eur J Cardiothorac Surg. 2005 Apr;27(4):592-8. doi: 10.1016/j.ejcts.2005.01.030.
• Popovsky MA. Transfusion-related acute lung injury: three decades of progress but miles to go before we sleep. Transfusion. 2015 May;55(5):930-4. doi: 10.1111/trf.13064. No abstract available.
• Roberson RS, Bennett-Guerrero E. Impact of red blood cell transfusion on global and regional measures of oxygenation. Mt Sinai J Med. 2012 Jan-Feb;79(1):66-74. doi: 10.1002/msj.21284.
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• Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2.
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Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Blood loss; Lumbar spine surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: IRB00200167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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