Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery

Blood Loss Clinical Trial

Official title:

Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058665
• Other study ID #: IRB00200167
• Status: Completed
• Start date: June 18, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Device:
• Floseal
Hemostatic agent

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

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