A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

NCT01285024 | Completed Results DMC

• 1 other identifier: CCF 10-916
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled, single-center study to assess the effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects. Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or any other hemostatic agent except those that are standard during a primary THA. The study will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.

Conditions

Arthritis

Keywords

total hip arthroplasty; transfusion; hemostat

Outcome Measures

Primary Outcomes (1)

• Transfusion Requirement

  Measure Title: Units of transfusion required

  intraoperative - 1 week postoperative

Secondary Outcomes (1)

• Total Hemoglobin Level Change

  day of surgery - 1 week postoperative

Study Arms (2)

Control

NO INTERVENTION

No Vitagel used during total hip arthroplasty

Vitagel

EXPERIMENTAL

Vitagel applied just prior to closure during total hip arthroplasty

Device: Vitagel

Interventions

Vitagel DEVICE

Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.

Vitagel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are scheduled for a primary unilateral THA;
• Are able and willing to provide voluntary written informed consent for participation in the study;
• Are between the ages of 18 and 85 at the time of surgery;
• Are willing to comply with all aspects of the treatment and evaluation period

You may not qualify if:

• Are known to be sensitive to any materials of bovine origin;
• Are undergoing a bilateral or revision THA;
• Patients predonating autologous blood.
• Patients with a preoperative platelet count of less than 100,000.
• Patients with a previous history of venous thromboembolism or deep vein thrombosis
• Medical condition requiring anticoagulation
• Currently using Coumadin
• History of Heparin induced thrombocytopenia or Lovenox induced thrombocytopenia
• Have a history of rheumatoid arthritis or inflammatory arthritis;
• Peripheral vascular disease.
• Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder.
• Patients with history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from this study if a baseline INR is greater than 1.3 or APTT greater than 32.4
• Have a history of failed treatment for abuse of, or are actively abusing, illegal drugs, solvents, or alcohol;
• Have a systemic infection or infection at site of surgery;
• Are a prisoner; and/or

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Orthovita d/b/a Stryker: collaborator
• Stryker Instruments: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: President and CEO Cleveland Clinic Florida
• Organization: Cleveland Clinic

barsouw@ccf.org

216-444-7515

Study Officials

• Wael K Barsoum, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chairman of Surgical Operations

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: December 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 11, 2017
• Results First Posted: April 18, 2016

Record last verified: 2017-03

Locations

US (1)