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

• ClinicalTrials.gov Identifier: NCT01230931
• Recruitment Status: Terminated
• First Posted: October 29, 2010
• Results First Posted: November 15, 2018
• Last Update Posted: December 11, 2018
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Catherine G. Ambrose, The University of Texas Health Science Center, Houston

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Catherine G Ambrose, PhD; The University of Texas Health Science Center, Houston

More Information

Additional Information:

UT-Houston Department of Orthopaedic Surgery 

Publications:

Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009 Dec;17(12):727-36. Review.

Gardner MJ, Demetrakopoulos D, Klepchick PR, Mooar PA. The efficacy of autologous platelet gel in pain control and blood loss in total knee arthroplasty. An analysis of the haemoglobin, narcotic requirement and range of motion. Int Orthop. 2007 Jun;31(3):309-13. Epub 2006 Jul 1.

Zavadil DP, Satterlee CC, Costigan JM, Holt DW, Shostrom VK. Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. J Extra Corpor Technol. 2007 Sep;39(3):177-82.

Everts PA, Devilee RJ, Brown Mahoney C, Eeftinck-Schattenkerk M, Box HA, Knape JT, van Zundert A. Platelet gel and fibrin sealant reduce allogeneic blood transfusions in total knee arthroplasty. Acta Anaesthesiol Scand. 2006 May;50(5):593-9.

Horstmann WG, Slappendel R, van Hellemondt GG, Wymenga AW, Jack N, Everts PA. Autologous platelet gel in total knee arthroplasty: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 2011 Jan;19(1):115-21. doi: 10.1007/s00167-010-1207-0. Epub 2010 Jul 18.

Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5.

Wang GJ, Goldthwaite CA Jr, Burks S, Crawford R, Spotnitz WD; Orthopaedic Investigators Group. Fibrin sealant reduces perioperative blood loss in total hip replacement. J Long Term Eff Med Implants. 2003;13(5):399-411.

Sherman R, Chapman WC, Hannon G, Block JE. Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial. Orthopedics. 2001 Feb;24(2):137-41.

Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8.

Cillo JE Jr, Marx RE, Stevens MR. Evaluation of autologous platelet-poor plasma gel as a hemostatic adjunct after posterior iliac crest bone harvest. J Oral Maxillofac Surg. 2007 Sep;65(9):1734-8.

Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts--blood transfusion. N Engl J Med. 1999 Feb 11;340(6):438-47. Review.

Busch MP, Kleinman SH, Nemo GJ. Current and emerging infectious risks of blood transfusions. JAMA. 2003 Feb 26;289(8):959-62.

• 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
• Results First Posted: November 15, 2018
• Last Update Posted: December 11, 2018
• Last Verified: November 2018

• 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:

Fractures, Bone; Intra-Articular Fractures; Wounds and Injuries