ArthritisNCT01285024
A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty
A study testing Vitagel in people with Arthritis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled, single-center study to assess the effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Vitagel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are scheduled for a primary unilateral THA;
- Are able and willing to provide voluntary written informed consent for participation in the study;
- Are between the ages of 18 and 85 at the time of surgery;
- Are willing to comply with all aspects of the treatment and evaluation period
Who cannot join
- Are known to be sensitive to any materials of bovine origin;
- Are undergoing a bilateral or revision THA;
- Patients predonating autologous blood.
- Patients with a preoperative platelet count of less than 100,000.
- Patients with a previous history of venous thromboembolism or deep vein thrombosis
- Medical condition requiring anticoagulation
Show all 17Show fewer
- Currently using Coumadin
- History of Heparin induced thrombocytopenia or Lovenox induced thrombocytopenia
- Have a history of rheumatoid arthritis or inflammatory arthritis;
- Peripheral vascular disease.
- Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder.
- Patients with history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from this study if a baseline INR is greater than 1.3 or APTT greater than 32.4
- Have a history of failed treatment for abuse of, or are actively abusing, illegal drugs, solvents, or alcohol;
- Have a systemic infection or infection at site of surgery;
- Are a prisoner; and/or
- Are pregnant or nursing.
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, randomized, controlled, single-center study to assess the effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects. Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or any other hemostatic agent except those that are standard during a primary THA. The study will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.
Read the detailed description
Vitagel Surgical Hemostat is composed of microfibrillar collagen and thrombin in combination with autologous plasma. It is applied to the surgical site as a sprayable liquid which then forms a collagen/fibrin gel matrix (containing the patients activated platelets) which adheres to the bleeding site. This matrix provides hemostasis and facilitates healing. Vitagel is resorbed in approximately 30 days. It is easily prepared by the OR staff in minutes and only requires ~10mL's of the patient's blood per Vitagel 4.5ml kit. Compared to other hemostatic agents on the market today, Vitagel has the advantages of not containing pooled human donor blood proteins, aprotinin, or tranexamic acid.
Vitagel has been studied in multiple surgical specialties to demonstrate safety and efficacy. Vitagel was studied in orthopedic procedures, both on iliac crest donor sites and sternal edges, during its IDE studies for FDA approval. Vitagel was granted broad indications for use by the FDA in 2000 as an adjunct to hemostasis. It was formerly marketed under the name CoStasis® Surgical Hemostat, by Cohesion Technologies, Palo Alto, CA.
The use of a surgical hemostat in joint arthroplasty may substantially decrease post-operative blood loss, which may reduce patient morbidity, length of hospital stay, and costs by potentially eliminating the need for transfusions and drains.
Total Hip Arthroplasty (THA) is associated with post-operative blood loss and frequently requires the transfusion of blood products. Increased concern over the risks of blood transfusion, which include transmission of viral diseases, such as HIV, Hepatitis, and CMV as well as transfusion reactions, has perpetuated the search for new methods of blood conservation in orthopedic surgery. There exists considerable variation in the protocols that are used to optimize hemostasis and minimize post-operative blood loss in patients undergoing THA. Some methods used include pre-operative hemodilution and hypotensive anesthesia; however, these methods have associated risks, require careful monitoring, and can prolong the operative time. Another method used is intra-operative and post-operative salvage of blood with re-infusion which requires continuous monitoring and is limited to patients who bled heavily during the initial period following surgery, because the blood should be collected over a period of not more than six hours. The transfusion of autologous pre-donated blood is also commonly used in THA surgery. While autologous pre-donated blood is not associated with the risk of viral disease transmission, the rates of administrative error and bacterial overgrowth (the factors most frequently associated with immediate post-transfusion deaths) are comparable with those associated with the use of homologous blood. The collection of pre-donated blood requires special programs and scheduling. Studies have indicated that the use of autologous blood transfusions may have little health benefit at considerable costs.
During surgery, meticulous electrocautery, helps minimize both acute blood loss and post-operative drainage. No uniform guidelines exist regarding the use of post-operative drains in THA. Some surgeons use drain systems that allow re-infusion of the erythrocytes, others prefer simple vacuum drains. Still others do not use drains at all. There are conflicting data regarding the efficacy of closed suction drains. Some studies have shown that bleeding may be potentiated by suction drainage. Other studies have shown that drains can lead to complications such as infection, increased blood loss, need for blood transfusions, breakage in the drain tube, and pain during drain tube removal. Thus, the need for adequate hemostasis in THA remains apparent.
To date there have been limited published studies on the use of hemostatic agents during THA procedures. However, even in a relatively low number of patients these studies have shown that the use of hemostatic agents is a safe and effective means to reduce blood loss and the need for and rate of blood transfusions.
- Conditions
- Arthritis
- Being tested
- Vitagel
- Keywords
- total hip arthroplasty, transfusion, hemostat
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitagelDevice
Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No Vitagel used during total hip arthroplasty |
| Vitagel | Experimental | Vitagel applied just prior to closure during total hip arthroplasty Receives: Device: Vitagel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion Requirement
Measure Title: Units of transfusion required
Measured: intraoperative - 1 week postoperative
Secondary outcomes (1)
Total Hemoglobin Level Change
Total hemoglobin level change from preop to postoperative discharge.
Measured: day of surgery - 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2014
- Study completionDec 2014
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.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Orthovita d/b/a Stryker, Stryker Instruments
- Responsible party
- Principal investigator, Wael Barsoum, The Cleveland Clinic
- Investigators
- Wael K Barsoum, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285024
- Sponsor's protocol ID
- CCF 10-916
- Status last verified
- Mar 2017
- First submitted
- 26 Jan 2011
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01285024
- Acronym / sponsor ID
- CCF 10-916
- Conditions
- Arthritis
- Keywords
- total hip arthroplasty, transfusion, hemostat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Orthovita d/b/a Stryker, Stryker Instruments
- Study start
- Dec 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled, single-center study to assess the effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects. Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or any other hemostatic agent except those that are standard during a primary THA. The study will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.
Detailed description
Vitagel Surgical Hemostat is composed of microfibrillar collagen and thrombin in combination with autologous plasma. It is applied to the surgical site as a sprayable liquid which then forms a collagen/fibrin gel matrix (containing the patients activated platelets) which adheres to the bleeding site. This matrix provides hemostasis and facilitates healing. Vitagel is resorbed in approximately 30 days. It is easily prepared by the OR staff in minutes and only requires ~10mL's of the patient's blood per Vitagel 4.5ml kit. Compared to other hemostatic agents on the market today, Vitagel has the advantages of not containing pooled human donor blood proteins, aprotinin, or tranexamic acid.
Vitagel has been studied in multiple surgical specialties to demonstrate safety and efficacy. Vitagel was studied in orthopedic procedures, both on iliac crest donor sites and sternal edges, during its IDE studies for FDA approval. Vitagel was granted broad indications for use by the FDA in 2000 as an adjunct to hemostasis. It was formerly marketed under the name CoStasis® Surgical Hemostat, by Cohesion Technologies, Palo Alto, CA.
The use of a surgical hemostat in joint arthroplasty may substantially decrease post-operative blood loss, which may reduce patient morbidity, length of hospital stay, and costs by potentially eliminating the need for transfusions and drains.
Total Hip Arthroplasty (THA) is associated with post-operative blood loss and frequently requires the transfusion of blood products. Increased concern over the risks of blood transfusion, which include transmission of viral diseases, such as HIV, Hepatitis, and CMV as well as transfusion reactions, has perpetuated the search for new methods of blood conservation in orthopedic surgery. There exists considerable variation in the protocols that are used to optimize hemostasis and minimize post-operative blood loss in patients undergoing THA. Some methods used include pre-operative hemodilution and hypotensive anesthesia; however, these methods have associated risks, require careful monitoring, and can prolong the operative time. Another method used is intra-operative and post-operative salvage of blood with re-infusion which requires continuous monitoring and is limited to patients who bled heavily during the initial period following surgery, because the blood should be collected over a period of not more than six hours. The transfusion of autologous pre-donated blood is also commonly used in THA surgery. While autologous pre-donated blood is not associated with the risk of viral disease transmission, the rates of administrative error and bacterial overgrowth (the factors most frequently associated with immediate post-transfusion deaths) are comparable with those associated with the use of homologous blood. The collection of pre-donated blood requires special programs and scheduling. Studies have indicated that the use of autologous blood transfusions may have little health benefit at considerable costs.
During surgery, meticulous electrocautery, helps minimize both acute blood loss and post-operative drainage. No uniform guidelines exist regarding the use of post-operative drains in THA. Some surgeons use drain systems that allow re-infusion of the erythrocytes, others prefer simple vacuum drains. Still others do not use drains at all. There are conflicting data regarding the efficacy of closed suction drains. Some studies have shown that bleeding may be potentiated by suction drainage. Other studies have shown that drains can lead to complications such as infection, increased blood loss, need for blood transfusions, breakage in the drain tube, and pain during drain tube removal. Thus, the need for adequate hemostasis in THA remains apparent.
To date there have been limited published studies on the use of hemostatic agents during THA procedures. However, even in a relatively low number of patients these studies have shown that the use of hemostatic agents is a safe and effective means to reduce blood loss and the need for and rate of blood transfusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No Vitagel used during total hip arthroplasty |
| Vitagel | Experimental | Device: VitagelVitagel applied just prior to closure during total hip arthroplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are scheduled for a primary unilateral THA;
- Are able and willing to provide voluntary written informed consent for participation in the study;
- Are between the ages of 18 and 85 at the time of surgery;
- Are willing to comply with all aspects of the treatment and evaluation period
Key exclusion criteria (17 listed)
- Are known to be sensitive to any materials of bovine origin;
- Are undergoing a bilateral or revision THA;
- Patients predonating autologous blood.
- Patients with a preoperative platelet count of less than 100,000.
- Patients with a previous history of venous thromboembolism or deep vein thrombosis
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 |
|---|---|---|
| VitagelTwo 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule. | Device | Vitagel |
Primary outcome
Transfusion Requirement
Time frame: intraoperative - 1 week postoperative
Measure Title: Units of transfusion required
1 secondary outcome
Total Hemoglobin Level Change
Time frame: day of surgery - 1 week postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wael K Barsoum, MD principal investigator
The Cleveland Clinic
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 Arthritis, run by The Cleveland Clinic 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 11 Apr 2017. 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 18 Apr 2016). 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?
Transfusion Requirement (time frame: intraoperative - 1 week postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2017.