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

Brief Summary

Official Title: “Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat”

Fractures of the acetabulum are considered rare in the general community, but are quite common in major metropolitan areas and tertiary care centers. These fractures are some of the most complex and challenging injuries to successfully treat in the orthopaedic field. Extensile surgical exposures are required to access this unique structure that comprises the cup of the hip joint. Large skin incisions, significant soft tissue dissection, and elevation of periosteum and muscle from the intact and fractured fragments are often required for anatomic reductions of the acetabulum and good outcomes. Thus, there are many sources of intra-operative bleeding that can sum up to require strategies aimed at preventing bleeding or replacing blood loss.

Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required and cost over $400 per hour. Disposable products are also required for each patient. While blood loss can be great, often not enough blood is captured, processed, and available for return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is often on short supply. The cost of processing, testing, and transfusion is also high: minimum of $260 per standard unit of packed red blood cells. While risks of disease transmission are rare, they exist and can have serious consequences to patients. Transmission can include CMV (common), Hepatitis C (1:1,600,000), HIV (1:1,800,000), and bacteria (1:500,000). Transfusion reactions are more common and include febrile reactions (1:100), allergic reactions (1:100), hemolytic reactions (less common), and transfusion-related acute lung injury (1:5000).

Decreased operative times, aggressive electrocautery, ligation of identifiable vessels, minimal soft tissue dissection or stripping, topical agents such as gel foams, and thrombins are possible and available. But still, significant blood losses persist. Over the past decade, platelet gel products and fibrin sealants have been developed and provide another possible solution. There are some retrospective studies in the arthroplasty literature indicating these are good hemostatic agents. There is also some literature from the general, oral and maxillofacial, and spine surgical fields indicated these topical agents decrease intra-operative blood loss. But there are no large prospective, randomized studies in orthopedics, particularly traumatology, supporting the use of surgical hemostats.

This study protocol will use one surgical hemostat (Vitagel, Stryker). The study is a prospective, randomized controlled trial to evaluate this type of topical agent's role as a hemostatic agent in certain acetabular fracture types that require a non-extensile, posterior approach. Three fellowship-trained traumatologists will be involved: Drs. Milan Sen, Tim Achor, Josh Gary, Mark Prasarn, John Munz, and Andrew Burgess. Dr. Ambrose will assist in analyzing the data and statistical outcomes.

Purpose of Project. The purpose of our 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, a secondary endpoint will be incidence of wound dehiscence and/or infections.

The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2012

Detailed Clinical Trial Description

Patients will be identified upon admission to Memorial Hermann-TMC, starting January 1, 2010, who fulfill the following inclusion criteria:

1. Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons.

2. 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

3. Ages 18-65

4. Patient or family must consent to the research protocol

Potential study candidates will be excluded based on the following criteria

1. Not meeting the aforementioned inclusion criteria

2. Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources)

3. Revision surgery

4. Surgery occurring more than two weeks post-injury

5. History of blood dyscrasias or immunocompromised patients

6. Patients with medical conditions requiring anticoagulation or INR above 1.5

7. Obese patients (BMI >35)

8. Known ongoing infection (local or systemic)

9. Pregnant women

Consent Procedure: After admission, potential candidates will be recruited by either a resident, physician assistant, or nurse practitioner. The research protocol will be presented along with the risks and benefits of both the control and treatment groups. Both consent and HIPAA documentation with be signed if the patient is agreeable. Study Description. This will be a prospective, randomized, controlled trial lasting one year at a minimum. Once consent is obtained, the patient will be randomized by use of the sealed envelope method. The patient will not know to which group he/she is assigned. The control group will not receive the surgical hemostat and no blood draw will be necessary. The test group will include the use of the surgical hemostat. Both groups will receive standard intra- and perioperative care (i.e. cell save, blood transfusions as needed). At the time of enrollment, baseline information of each patient will be obtained by a questionnaire, including age, sex, BMI, medical co-morbidities, history of alcohol, tobacco, or drugs. Randomization should also account for and patients will be stratified by pre-operative ASA, ISS, and fracture type.

A Data collection sheet will be included in the chart. It will be colored and flagged. Nursing staff will input the following data:

1. Pre-operative hemoglobin levels (routine AM labs: generally 12AM-2AM for STICU and SIMU patients, 4AM-6AM for floor patients)

2. Recovery room post-operative hemoglobin levels

3. Post-operative hemoglobin levels (routine AM labs: generally 12AM-2AM for STICU and SIMU patients, 4AM-6AM for floor patients). For cases ending after 5PM, hemoglobin level will be taken on a fourth AM to ensure that a full 72 hours is monitored

4. Post-operative transfusion requirements for 72 hours

OR nursing staff will record intra-operative data, including:

1. Intra-operative blood loss as measured by cell saver

2. Intra-operative transfusion requirements

3. Intra-operative complications

Orthopaedic resident or extended provider (N.P. or P.A.) will record any evidence of wound complications, including infections requiring antibiotics or surgical debridement, dehiscence or necrosis requiring additional treatments (packing or wound vac) and/or surgeries throughout the hospital stay.

Postoperative transfusions triggers will be as follows: Hemoglobin < 7 g/dL. Hemoglobin <10 g/dL in patients with known cardiovascular comorbidities. Any hemoglobin level in which the patient is symptomatic and the physician deems it necessary and in the best interest of the patient to transfuse blood. Examples include but are not limited to:

- Hypotension and shock.

- Chest pain, palpitations, and/or shortness of breath.

- Lightheadness or fatigue with physical therapy.

DVT chemoprophylaxis will be discontinued the morning prior to surgery and resumed 24 hours post operatively. Mechanical prophylaxis to be continued throughout as tolerated.

During surgery, a Vitagel representative will be present for aid the nurses in preparing the samples. Autologous blood draw (approximately 10cc) will be performed by the anesthesiologist in the operating room. This sample is passed to the nurse in the operating room, and he/she will centrifuge the sample. The resulting plasma will be transferred into a sterile syringe and delivered to the surgical field. The syringe with autologous fibrinogen and platelets(5cc) will be assembled side-by-side with the sterile bovine thrombin and collagen syringe (5cc), by either the surgical technician or surgeon. The applicator simultaneously mixes the two samples and sprays the surgical hemostat on the desired area. Sterile precautions are a maintained throughout, and the blood or plasma will not leave the operating room. The surgical hemostat will be applied first to dissected musculature (external rotators and abductors) after exposure of the fracture and second to the subcutaneous closure superficial to iliotibial band and gluteal fascia.

Interventions Used in this Clinical Trial

  • Biological: Vitagel topical surgical hemostat
    • Vitagel is topical 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Vitagel
    • The group of patients will receive the vitagel spray intra-operatively, along with all the other standards of care.
  • No Intervention: No Vitagel
    • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Intra-operative blood loss
    • Time Frame: The intra-operative blood will summed from the cell saver and lap count totals. This will be recorded on the data collection sheet prior to the patient leaving the operating room.
      Safety Issue?: No

Secondary Measures

  • Change in hemoglobin level
    • Time Frame: Hg levels will be monitored from the day of surgery to post-operative days 1,2, and 3. Change in Hg (from pre-op to post-op for each day) will be recorded on those specific days. There will be more data recorded after post-operative day 3.
      Safety Issue?: No
  • Amount of blood products transfused.
    • Time Frame: Number of blood products (pRBC and FFP) transfused in the first 3 post-op days will be recorded, as well as the amount of intra-operative salvaged blood transfused. After post-op day 3, no more data will be collected.
      Safety Issue?: No
  • Wound complications
    • Time Frame: Wound complications will be recorded from the day of surgery for an average of two weeks post-operatively. Thereafter, there will be no data collected.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 INR above 1.5
  • Obese patients (BMI >35)
  • Known ongoing infection (local or systemic)
  • Pregnant women

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: William Harvin, Chief Resident – Orthopaedic Surgery – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • William H Harvin, MD, Principal Investigator, Resident, Department of Orthopaedic Surgery, UTHSC-Houston
    • Milan K Sen, MD, Study Chair, Associate Professor, Department of Orthopaedic Surgery, UTHSC-Houston
  • Overall Contact(s)
    • William H Harvin, MD, 713-500-7012, william.harvin@uth.tmc.edu


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