Clinical trial NCT01230931: Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Official title: Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fracture Fixation
Intra-Articular Fractures
Acetabulum
Keywords: Acetabulum
Fracture
Hemostatis
Vitagel
Fibrin sealant
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Intra-operative Rate of Blood Volume Loss
timeFrame: at the time of surgery
Secondary outcomes:
measure: Change in Hemoglobin Level
timeFrame: baseline, post-operative day 1
measure: Change in Hemoglobin Level
timeFrame: baseline, post-operative day 2
measure: Change in Hemoglobin Level
timeFrame: baseline, post-operative day 3
measure: Volume of Blood Products Transfused
timeFrame: baseline through post-operative day 3
measure: Units of Packed Red Blood Cells (pRBCs) Transfused
timeFrame: baseline through post-operative day 3
measure: Units of Fresh Frozen Plasma (FFP) Transfused
timeFrame: baseline through post-operative day 3
measure: Volume of Intra-operative Salvaged Blood Transfused
timeFrame: baseline through post-operative day 3
measure: Number of Participants With a Wound Complication
timeFrame: at the time of discharge (about 2 weeks after surgery)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Catherine G Ambrose, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009 Dec;17(12):727-36. doi: 10.5435/00124635-200912000-00001.
citation: 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. doi: 10.1007/s00264-006-0174-z. Epub 2006 Jul 1.
citation: 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.
citation: 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. doi: 10.1111/j.1399-6576.2006.001005.x.
citation: 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.
citation: 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. doi: 10.2106/00004623-200110000-00007.
citation: 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. doi: 10.1615/jlongtermeffmedimplants.v13.i5.50.
citation: 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. doi: 10.3928/0147-7447-20010201-16.
citation: 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. doi: 10.2106/00004623-199911000-00010.
citation: 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. doi: 10.1016/j.joms.2006.09.008.
citation: 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. doi: 10.1056/NEJM199902113400606. No abstract available.
citation: Busch MP, Kleinman SH, Nemo GJ. Current and emerging infectious risks of blood transfusions. JAMA. 2003 Feb 26;289(8):959-62. doi: 10.1001/jama.289.8.959. No abstract available.