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Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements

Sponsor
Desert Orthopedic Center Medical Research Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT00958945
Collaborator
Baxter Healthcare Corporation (Industry)
500
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.

    Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.

    Secondary Data gathered will consist of the following:

    • patient Demographics

    • Component Profile

    • Length of Stay

    • Anesthesia used

    • Anesthesiologist

    • EBL

    • drain type

    • Amount of drainage fluid recorded at 12 hour increments until discharge

    • Amount of FloSeal used

    • Type of Arthroplasty

    500 patients in Total

    • 100 Historical Control Patients, knees - no FloSeal (retrospective)

    • 100 Patients, knees - 5mL FloSeal (retrospective)

    • 100 Patients, knees- 10mL FloSeal (prospective)

    • 100 Historical Control patients, hips-no FloSeal (retrospective)

    • 100 retrospective patients, hips-5mL of FloSeal (retrospective

    Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty
    Study Start Date :
    Sep 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    FloSeal - Knee - control

    100 Historical Control Patients, knees - no FloSeal (retrospective)
    FloSeal - Knee - 5ml

    100 Patients, knees - 5mL FloSeal (retrospective)
    FloSeal - Knee - 10ml

    100 Patients, knees- 10mL FloSeal (prospective)
    FloSeal - Hip - Control

    100 Historical Control patients, hips-no FloSeal (retrospective)
    FloSeal - Hip - 5ml

    100 retrospective patients, hips-5mL of FloSeal (retrospective)

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 95 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Total Knee and Total Hip Patients

      • Surgical Time less than 2 hours

      Exclusion Criteria:

      • Patients who require greater than 2 hour surgeries

      • Patients who are undergoing revision arthroplasty

      • Patients with known allergies to materials of bovine origin

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Desert Orthopedic Center Rancho Mirage California United States 92211

      Sponsors and Collaborators

      • Desert Orthopedic Center Medical Research Foundation
      • Baxter Healthcare Corporation

      Investigators

      • Principal Investigator: John H. Velyvis,, MD, Desert Orthopedic Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00958945
      Other Study ID Numbers:
      • FloSeal
      First Posted:
      Aug 14, 2009
      Last Update Posted:
      Aug 14, 2009
      Last Verified:
      Aug 1, 2009
      Keywords provided by , ,
      Postoperative Hematocrit
      Postoperative Hemoglobin

      Study Results

      No Results Posted as of Aug 14, 2009