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Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

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ClinicalTrials.gov Identifier: NCT01230931
Recruitment Status : Terminated (Study team left institution; no one remaining to finish study)
First Posted : October 29, 2010
Results First Posted : November 15, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Catherine G. Ambrose, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.

Condition or disease Intervention/treatment Phase
Fracture Fixation Intra-Articular Fractures Acetabulum Device: Vitagel Procedure: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
Actual Study Start Date : October 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Vitagel and Standard of Care
This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
Device: Vitagel
Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.

Procedure: Standard of care
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.

Active Comparator: Standard of Care
This group of patients will receive the standard of care for hemostasis in acetabular surgery (electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing). They will not receive the vitagel product.
Procedure: Standard of care
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.




Primary Outcome Measures :
  1. Intra-operative Rate of Blood Volume Loss [ Time Frame: at the time of surgery ]
    The amount of blood loss during the surgery as measured by cell saver and lap counts. The cell saver and lap count totals will be summed.


Secondary Outcome Measures :
  1. Change in Hemoglobin Level [ Time Frame: baseline, post-operative day 1 ]
    The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.

  2. Change in Hemoglobin Level [ Time Frame: baseline, post-operative day 2 ]
    The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.

  3. Change in Hemoglobin Level [ Time Frame: baseline, post-operative day 3 ]
    The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.

  4. Volume of Blood Products Transfused [ Time Frame: baseline through post-operative day 3 ]
    The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.

  5. Units of Packed Red Blood Cells (pRBCs) Transfused [ Time Frame: baseline through post-operative day 3 ]
    The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.

  6. Units of Fresh Frozen Plasma (FFP) Transfused [ Time Frame: baseline through post-operative day 3 ]
    The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.

  7. Volume of Intra-operative Salvaged Blood Transfused [ Time Frame: baseline through post-operative day 3 ]
    The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.

  8. Number of Participants With a Wound Complication [ Time Frame: at the time of discharge (about 2 weeks after surgery) ]
    The number of wound complications (dehiscence, infection) or the need to return to the operating to address a wound complication will be recorded. Wound complications will be recorded from the day of surgery until an average of two weeks post-operatively (this study is an acute care study, so no data will be collected after the initial hospital stay).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons.
  • Fixation must require a single non-extensile posterior approach (Kocher-Langenbeck)
  • Posterior wall, Posterior column, certain simple transverse and transverse associated with a posterior wall, T-type, and posterior wall-posterior column fracture types
  • Ages 18-65
  • Patient or family must consent to the research protocol

Exclusion Criteria:

  • Not meeting the aforementioned inclusion criteria
  • Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources)
  • Revision surgery
  • Surgery occurring more than two weeks post-injury
  • History of blood dyscrasias or immunocompromised patients
  • Patients with medical conditions requiring anticoagulation or international normalized ratio (INR) above 1.5
  • Obese patients (BMI >35)
  • Known ongoing infection (local or systemic)
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230931


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Catherine G Ambrose, PhD The University of Texas Health Science Center, Houston
Additional Information:
Publications:

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Responsible Party: Catherine G. Ambrose, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01230931    
Other Study ID Numbers: HSC-MS-09-0654
First Posted: October 29, 2010    Key Record Dates
Results First Posted: November 15, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018

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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
Keywords provided by Catherine G. Ambrose, The University of Texas Health Science Center, Houston:
Acetabulum
Fracture
Hemostatis
Vitagel
Fibrin sealant
Additional relevant MeSH terms:
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Fractures, Bone
Intra-Articular Fractures
Wounds and Injuries