Fracture FixationNCT01230931
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
A study testing Vitagel in people with Fracture Fixation and Intra-Articular Fractures, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fracture Fixation, Intra-Articular Fractures, Acetabulum
- What is being tested?
- Vitagel
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Obese patients (BMI >35)
- Known ongoing infection (local or systemic)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
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.
- Conditions
- Fracture Fixation, Intra-Articular Fractures, Acetabulum
- Being tested
- Vitagel, Standard of care
- Keywords
- Acetabulum, Fracture, Hemostatis, Vitagel, Fibrin sealant
- Medical subject headings
- Intra-Articular Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitagelDevice
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.
Standard of careProcedure or surgery
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.
| Study group | Role | What they receive |
|---|---|---|
| Vitagel and Standard of Care | Experimental | This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care. Receives: Device: Vitagel; Procedure: Standard of care |
| Standard of Care | Active comparator | 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. Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative Rate of Blood Volume Loss
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.
Measured: at the time of surgery
Secondary outcomes (8)
Change in Hemoglobin Level
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Measured: baseline, post-operative day 1
Change in Hemoglobin Level
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Measured: baseline, post-operative day 2
Change in Hemoglobin Level
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Measured: baseline, post-operative day 3
Volume of Blood Products Transfused
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.
Measured: baseline through post-operative day 3
Units of Packed Red Blood Cells (pRBCs) Transfused
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.
Measured: baseline through post-operative day 3
Units of Fresh Frozen Plasma (FFP) Transfused
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.
Measured: baseline through post-operative day 3
Volume of Intra-operative Salvaged Blood Transfused
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.
Measured: baseline through post-operative day 3
Number of Participants With a Wound Complication
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).
Measured: at the time of discharge (about 2 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Study team left institution; no one remaining to finish study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Fracture FixationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine G. Ambrose, The University of Texas Health Science Center, Houston
- Investigators
- Catherine G Ambrose, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230931
- Sponsor's protocol ID
- HSC-MS-09-0654
- Status last verified
- Nov 2018
- First submitted
- 18 Oct 2010
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 19948697Gardner 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.
PubMed 16816947Zavadil 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.
PubMed 17972452Everts 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.
PubMed 16643230Horstmann 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.
PubMed 20640848Wang 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.
PubMed 11679600Wang 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.
PubMed 14649578Sherman 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.
PubMed 11284596Levy 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.
PubMed 10565650Cillo 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.
PubMed 17719390Goodnough 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.
PubMed 9971869Busch 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.
PubMed 12597733
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
- ClinicalTrials.gov ID
- NCT01230931
- Acronym / sponsor ID
- HSC-MS-09-0654
- Conditions
- Fracture Fixation, Intra-Articular Fractures, Acetabulum
- Keywords
- Acetabulum, Fracture, Hemostatis, Vitagel, Fibrin sealant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team left institution; no one remaining to finish study
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Posted 15 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitagel and Standard of Care | Experimental | Device: Vitagel, Procedure: Standard of careThis group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care. |
| Standard of Care | Active comparator | Procedure: Standard of careThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitagelVitagel (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. | Device | Vitagel and Standard of Care |
| Standard of careStandard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing. | Procedure or surgery | Standard of Care, Vitagel and Standard of Care |
Primary outcome
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.
8 secondary outcomes
Change in Hemoglobin Level
Time frame: baseline, post-operative day 1
Change in Hemoglobin Level
Time frame: baseline, post-operative day 2
Change in Hemoglobin Level
Time frame: baseline, post-operative day 3
Volume of Blood Products Transfused
Time frame: baseline through post-operative day 3
Units of Packed Red Blood Cells (pRBCs) Transfused
Time frame: baseline through post-operative day 3
Units of Fresh Frozen Plasma (FFP) Transfused
Time frame: baseline through post-operative day 3
Volume of Intra-operative Salvaged Blood Transfused
Time frame: baseline through post-operative day 3
Number of Participants With a Wound Complication
Time frame: at the time of discharge (about 2 weeks after surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19948697Thoms 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.
- Background: PubMed 16816947Gardner 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.
- Background: PubMed 17972452Zavadil 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.
- Background: PubMed 16643230Everts 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.
- Background: PubMed 20640848Horstmann 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.
- Background: PubMed 11679600Wang 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.
- Background: PubMed 14649578Wang 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.
- Background: PubMed 11284596Sherman 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.
- Background: PubMed 10565650Levy 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.
- Background: PubMed 17719390Cillo 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.
- Background: PubMed 9971869Goodnough 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.
- Background: PubMed 12597733Busch 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.
- UT-Houston Department of Orthopaedic SurgeryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine G Ambrose, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitagel in people with Fracture Fixation and Intra-Articular Fractures, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative Rate of Blood Volume Loss (time frame: at the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230931, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.