Cardiovascular, Neurologic (Spine), and General SurgeryPhase 3NCT00196534
A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery
A Phase 3 study testing Human Thrombin and Bovine Thrombin in people with Cardiovascular, Neurologic (Spine), and General Surgery, run by Ethicon, Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular, Neurologic (Spine), and General Surgery
- What is being tested?
- Human Thrombin and Bovine Thrombin
- How many people
- 304 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2004to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, of any race, 18 years or older.
- Patients who have at least one bleeding site within the operative field that is mild (oozing or capillary bleeding) to moderate (gradual or steady bleeding) in intensity and which cannot be managed by surgical modalities because they are ineffective or impractical (Change 15, Amend 1).
- Patients scheduled for any of the following elective surgical procedures:
- Cardiovascular Procedures - aortic surgery such as aneurysmectomy, aneurysmoplasty, aneurysmorrhaphy, aneurysmotomy and bypass procedures involving the aorta; major coronary bypass procedures including primary bypass surgery and re-do procedures. Peripheral vascular procedures to include femoral-popliteal bypass, femoral-femoral bypass, or other peripheral vascular procedures requiring vessel grafting with native or prosthetic grafts including Polytetrafluoroethylene (PTFE) grafts; carotid endarterectomies. The sternum is excluded as a Target Site. Bleeding sites evaluated during these procedures may include soft tissues (e.g. mammary bed, retroperitoneal fat/connective tissues and adhesions) and needle hole bleeding of prosthetic graft material (Change 6, Amend 1).
- Neurosurgical (spine) Procedures- primary lumbar laminectomy and laminectomy with fusion (fusion must be done after the time to hemostasis assessment). Re-do laminectomy, removal of tumors/lesions during laminectomy, cervical, or thoracic laminectomy procedures will be excluded. Bleeding sites evaluated may include periosteum, bone marrow, venous plexus (Change 7, Amend 1).
- General Surgery or Post-Traumatic (hemodynamically stable and non-coagulopathic) procedures: bowel and colon resections, retroperitoneal dissections/resections, and procedures involving the resection of any solid abdominal organ such as a splenectomy, liver resection, nephrectomy, splenorrhaphy, and pancreatectomy. Bleeding sites evaluated may include soft tissues (e.g. bowel mesentery, adhesions, lymph node beds, sacral venous plexus, etc.) and parenchymal organ bleeds (cut surface of resected liver, spleen, etc., excluding cut surface of kidney) (Amendment #2, Change 44). Bowel anastomoses sites will not be included (Change 8, Amend 1).
- Patient, or the patient's legally authorized representative, must provide legally effective informed consent prior to any participation in the study. (Amendment #2, Change 41)
Who cannot join
- Patients with bleeding diathesis, pathologic coagulopathy, systemic disorders, or autoimmune, immunodeficiency diseases or any other disorder that may interfere with hemostasis.
- Patients who have had a pre-operative laboratory finding that was considered clinically significant (as determined by the Investigator) for CBC (HCT, Hgb, white blood cell differential, platelet count, and Red Blood Cell (RBC) indices (MCH, MCV, MCHC)), prothrombin time (PT), or activated partial thromboplastin time (aPTT).
- Patients who have used anticoagulant, antiplatelet or nonsteroidal anti-inflammatory analgesic (NSAID) within 5 days prior to surgery (the use of ASA or aprotinin is permitted).
- Patients with known antibodies to bovine thrombin preparations.
- Patients receiving an organ transplant (liver, heart, kidney, etc.).
- Patients who are morbidly obese (Body Mass Index > 35).
Show all 13Show fewer
- Patients with acute or chronic liver failure (Amendment #2, Change 42).
- Patients with all severe (brisk or forceful) bleeding site(s).
- Patients with an ongoing infection at the operative site.
- Patients who are known alcohol and/or drug abusers.
- Female patients who are pregnant or nursing.
- Patients who have uncontrolled diabetes mellitus (blood glucose levels >400 mg/dl) as determined by the Investigator based on medical history (Change 14, Admin. Change 2).
- Patients who have participated in another investigational drug or device research within 30 days of enrollment.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Neurospine Center of Wisconsin
Appleton, Wisconsin, 54913
Union Memorial Hospital
Baltimore, Maryland, 21218
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Cooper University Hospital
Camden, New Jersey, 08103
MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030
Borgess Research Institute
Kalamazoo, Michigan, 49048
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Ochsner Clinic
New Orleans, Louisiana, 70121
University of Nebrask Medical Center
Omaha, Nebraska, 68105
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Vacular Surgery Associates
Santa Monica, California, 90404
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Scott and White Hospital
Temple, Texas, 76508
Northwest NeuroSpecialists, PPLC
Tucson, Arizona, 85741
About this study
Official title: A Comparative Evaluation of Human Thrombin Versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (Spine) and General Surgery Procedures.
The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
- Being tested
- Human Thrombin, Bovine Thrombin
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human ThrombinDrug
Bovine ThrombinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in achieving hemostasis.
Secondary outcomes (6)
Success in achieving hemostasis after application
Estimated intraoperative blood loss
Procedure duration
Time in specialty units
Length of hospital stay
Incidence of adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular, Neurologic (Spine), and General SurgeryStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 304 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196534
- Sponsor's protocol ID
- 400-04-005
- Status last verified
- Aug 2007
- First submitted
- 12 Sep 2005
- Last updated
- 28 Aug 2007
- Results posted
- No
Publications
Doria C, Fischer CP, Wood CG, Li PM, Marra S, Hart J. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin. 2008 Mar;24(3):785-94. doi: 10.1185/030079908X273426. Epub 2008 Jan 31.
PubMed 18241525
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Human Thrombin Versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (Spine) and General Surgery Procedures.
- ClinicalTrials.gov ID
- NCT00196534
- Acronym / sponsor ID
- 400-04-005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Nov 2004
- Study completion
- Jul 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients, of any race, 18 years or older.
- Patients who have at least one bleeding site within the operative field that is mild (oozing or capillary bleeding) to moderate (gradual or steady bleeding) in intensity and which cannot be managed by surgical modalities because they are ineffective or impractical (Change 15, Amend 1).
- Patients scheduled for any of the following elective surgical procedures:
- Patient, or the patient's legally authorized representative, must provide legally effective informed consent prior to any participation in the study. (Amendment #2, Change 41)
Key exclusion criteria (13 listed)
- Patients with bleeding diathesis, pathologic coagulopathy, systemic disorders, or autoimmune, immunodeficiency diseases or any other disorder that may interfere with hemostasis.
- Patients who have had a pre-operative laboratory finding that was considered clinically significant (as determined by the Investigator) for CBC (HCT, Hgb, white blood cell differential, platelet count, and Red Blood Cell (RBC) indices (MCH, MCV, MCHC)), prothrombin time (PT), or activated partial thromboplastin time (aPTT).
- Patients who have used anticoagulant, antiplatelet or nonsteroidal anti-inflammatory analgesic (NSAID) within 5 days prior to surgery (the use of ASA or aprotinin is permitted).
- Patients with known antibodies to bovine thrombin preparations.
- Patients receiving an organ transplant (liver, heart, kidney, etc.).
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 |
|---|---|---|
| Human Thrombin | Drug | – |
| Bovine Thrombin | Drug | – |
Primary outcome
Success in achieving hemostasis.
6 secondary outcomes
Success in achieving hemostasis after application
Estimated intraoperative blood loss
Procedure duration
Time in specialty units
Length of hospital stay
Incidence of adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2007.
- Derived from this study: PubMed 18241525Doria C, Fischer CP, Wood CG, Li PM, Marra S, Hart J. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin. 2008 Mar;24(3):785-94. doi: 10.1185/030079908X273426. Epub 2008 Jan 31.
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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human Thrombin and Bovine Thrombin in people with Cardiovascular, Neurologic (Spine), and General Surgery, run by Ethicon, Inc. at 17 sites 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 7 inclusion and 13 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 28 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success in achieving hemostasis.. 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 NCT00196534, which also lists 1 linked publication.
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 28 Aug 2007.