Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery

NCT04058665 | Completed FDA Device

• 1 other identifier: IRB00200167
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss

Keywords

Lumbar spine surgery; Blood loss

Outcome Measures

Primary Outcomes (1)

• Total blood loss

  Cubic centimeters (cm\^3) of blood loss throughout the operation.

  1 week

Secondary Outcomes (10)

• Length of hospital stay

  Up to 1 month

• Number of postoperative infections

  Up to 3 months

• Number of transfusion complications

  Up to 1 month

• Number of medical complications

  Up to 1 month

• Overall cost of care during time in hospital

  Up to 1 year

Study Arms (1)

Observational group

No intervention performed. This is the overall group that will be retrospectively assessed for different variables pertaining to blood loss.

Device: Floseal

Interventions

Floseal DEVICE

Hemostatic agent

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing lumbar spine surgery at Johns Hopkins Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

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MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel M Sciubba, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: June 18, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 14, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)