Surgical HemostasisPhase 3NCT00245336
Study of Recombinant Human Thrombin for Bleeding During Surgery
A Phase 3 study testing rThrombin and bovine thrombin in people with Surgical Hemostasis, run by ZymoGenetics at 29 sites in United States.
Trial summary
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Hemostasis
- What is being tested?
- rThrombin and bovine thrombin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 29 sitesUnited States
- Study dates
- Oct 2005to 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
- Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access
Who cannot join
- Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery
- Subject has history of heparin-induced thrombocytopenia
- Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment
- Subject has received blood products within 24 hours prior to surgery
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Methodist Hospital
Arcadia, California, 91007
Vascular Surgery Associates
Baton Rouge, Louisiana, 70809
Cardio Thoracic Surgeons, P.C.
Birmingham, Alabama, 35213
Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist Montclair
Birmingham, Alabama, 35235
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Virginia
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northwestern University Vascular Surgery
Chicago, Illinois, 60611
VAMC Clinical Research Center
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
University of North Texas Science Center at Fort Worth
Fort Worth, Texas, 76107
Glendale Adventist Medical Center
Glendale, California, 91206
Indiana Spine Group
Indianapolis, Indiana, 46260
Bluegrass Orthopedics/Bluegrass Musculoskeletal Research
Lexington, Kentucky, 40509
University of Southern California, Keck School of Medicine
Los Angeles, California, 90033
University of Southern California, Keck School of Medicine
Los Angeles, California, 90333
Physician's Research Options, LLC/The Intermountain Spine Institute
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Tulane University Abdominal Transplant
New Orleans, Louisiana, 70112
Mt. Sinai School of Medicine
New York, New York, 10029
Huntington Memorial Hospital
Pasadena, California, 91105
Baptist Clinical Research
Pensacola, Florida, 32501
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84132
Clinical Trials of Texas
San Antonio, Texas, 78229
Virginia Mason Medical Center
Seattle, Washington, 98101
Harborview Medical Center
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.
Read the detailed description
This is a Phase 3 multiple site, randomized, double-blind, controlled trial designed to evaluate the comparative efficacy and safety of rhThrombin and bovine thrombin in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access.
After establishing eligibility, subjects will be randomized in a 1:1 ratio to receive rhThrombin (1000 U/mL) or bovine thrombin (1000 U/mL). During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or bovine thrombin) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s) and time to hemostasis (TTH) will be assessed for up to 10 minutes. Bleeding appropriate for TTH evaluation is defined as mild to moderate bleeding, either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities. Blinded study drug may also be used at additional appropriate bleeding sites. Study participants will have follow-up visits at about 2 days and 1 month after surgery. Approximately 400 to 600 patients will participate in the study. The final sample size will be determined based on blinded interim results.
- Conditions
- Surgical Hemostasis
- Being tested
- rThrombin, bovine thrombin
- Keywords
- hemostasis, surgery, hemostatics, randomized controlled trial, phase 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rThrombinBiological
1000 U/mL applied topically in combination with absorbable gelatin sponge
bovine thrombinDrug
Also called Thrombin-JMI
1000 U/mL applied topically in combination with absorbable gelatin sponge
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | rThrombin Receives: Biological: rThrombin |
| 2 | Active comparator | bThrombin Receives: Drug: bovine thrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes
Measured: 10 minutes
Secondary outcomes (3)
Incidence and severity of adverse events
Measured: Up to 29 days
Incidence and grade of clinical laboratory abnormalities
Measured: Up to 29 days
Incidence of anti-product antibodies
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical HemostasisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZymoGenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas C Reynolds, MD, PhD, Study director, ZymoGeneticsWilliam Chapman, MD, Principal investigator, Washington University School of MedicineKenneth Renkens, MD, Principal investigator, Indiana Spine GroupFred Weaver, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245336
- Sponsor's protocol ID
- 499E01
- Status last verified
- Mar 2009
- First submitted
- 25 Oct 2005
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weaver FA, Lew W, Granke K, Yonehiro L, Delange B, Alexander WA; Study Investigators. A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures. J Vasc Surg. 2008 Jun;47(6):1266-73. doi: 10.1016/j.jvs.2008.01.034. Epub 2008 Apr 28.
PubMed 18440754Chapman WC, Singla N, Genyk Y, McNeil JW, Renkens KL Jr, Reynolds TC, Murphy A, Weaver FA. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007 Aug;205(2):256-65. doi: 10.1016/j.jamcollsurg.2007.03.020. Epub 2007 Jun 27.
PubMed 17660072
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis
- ClinicalTrials.gov ID
- NCT00245336
- Acronym / sponsor ID
- 499E01
- Conditions
- Surgical Hemostasis
- Keywords
- hemostasis, surgery, hemostatics, randomized controlled trial, phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- ZymoGeneticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Oct 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 determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.
Detailed description
This is a Phase 3 multiple site, randomized, double-blind, controlled trial designed to evaluate the comparative efficacy and safety of rhThrombin and bovine thrombin in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access.
After establishing eligibility, subjects will be randomized in a 1:1 ratio to receive rhThrombin (1000 U/mL) or bovine thrombin (1000 U/mL). During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or bovine thrombin) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s) and time to hemostasis (TTH) will be assessed for up to 10 minutes. Bleeding appropriate for TTH evaluation is defined as mild to moderate bleeding, either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities. Blinded study drug may also be used at additional appropriate bleeding sites. Study participants will have follow-up visits at about 2 days and 1 month after surgery. Approximately 400 to 600 patients will participate in the study. The final sample size will be determined based on blinded interim results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: rThrombinrThrombin |
| 2 | Active comparator | Drug: bovine thrombinbThrombin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access
Key exclusion criteria (4 listed)
- Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery
- Subject has history of heparin-induced thrombocytopenia
- Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment
- Subject has received blood products within 24 hours prior to surgery
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 |
|---|---|---|
| rThrombin1000 U/mL applied topically in combination with absorbable gelatin sponge | Biological | 1 |
| bovine thrombinAlso: Thrombin-JMI1000 U/mL applied topically in combination with absorbable gelatin sponge | Drug | 2 |
Primary outcome
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes
Time frame: 10 minutes
3 secondary outcomes
Incidence and severity of adverse events
Time frame: Up to 29 days
Incidence and grade of clinical laboratory abnormalities
Time frame: Up to 29 days
Incidence of anti-product antibodies
Time frame: Up to 29 days
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 9 Mar 2009.
- Derived from this study: PubMed 18440754Weaver FA, Lew W, Granke K, Yonehiro L, Delange B, Alexander WA; Study Investigators. A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures. J Vasc Surg. 2008 Jun;47(6):1266-73. doi: 10.1016/j.jvs.2008.01.034. Epub 2008 Apr 28.
- Derived from this study: PubMed 17660072Chapman WC, Singla N, Genyk Y, McNeil JW, Renkens KL Jr, Reynolds TC, Murphy A, Weaver FA. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007 Aug;205(2):256-65. doi: 10.1016/j.jamcollsurg.2007.03.020. Epub 2007 Jun 27.
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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.
Thomas C Reynolds, MD, PhD study director
ZymoGenetics
William Chapman, MD principal investigator
Washington University School of Medicine
Kenneth Renkens, MD principal investigator
Indiana Spine Group
29 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 rThrombin and bovine thrombin in people with Surgical Hemostasis, run by ZymoGenetics at 29 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 1 inclusion and 4 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 9 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes (time frame: 10 minutes). 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 NCT00245336, which also lists 2 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 9 Mar 2009.