TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
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| ClinicalTrials.gov Identifier: NCT01192022 |
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Recruitment Status :
Completed
First Posted : August 31, 2010
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Brief Summary:
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemorrhage | Biological: TachoSil® Device: Surgicel® Original | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 253 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | May 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bleeding
Drug Information available for:
TachoSil
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: TachoSil®
TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
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Biological: TachoSil®
Intraoperative application as secondary hemostatic treatment |
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Active Comparator: Surgicel® Original
Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
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Device: Surgicel® Original
Intraoperative application as secondary hemostatic treatment |
Primary Outcome Measures :
- Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes [ Time Frame: within 3 minutes ]3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Secondary Outcome Measures :
- Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes [ Time Frame: within 5 minutes ]3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
- Time to Intraoperative Hemostasis at Target Bleeding Site [ Time Frame: 10 minutes ]The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
- Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
- Need for additional supportive hemostatic treatment
- Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes
Exclusion Criteria:
- Indication for emergency surgery
- Known coagulopathy (as judged relevant by the investigator)
- Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
- Patient unwilling to receive blood products
- Known current alcohol or drug abuse
- Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
- Dry surgical field of the targeted application area
- Occurrence of any serious surgical complication
- Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
- Application of topical hemostatic material on the liver resection wound
- Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192022
Locations
| United States, California | |
| Los Angeles, California, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Massachusetts | |
| Burlington, Massachusetts, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Newark, New Jersey, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Tennessee | |
| Memphis, Tennessee, United States | |
| Nashville, Tennessee, United States | |
| United States, Virginia | |
| Charlottesville, Virginia, United States | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States | |
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director | Takeda |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT01192022 |
| Other Study ID Numbers: |
TC-2402-040-SP U1111-1130-9121 ( Registry Identifier: WHO ) |
| First Posted: | August 31, 2010 Key Record Dates |
| Results First Posted: | November 25, 2015 |
| Last Update Posted: | November 25, 2015 |
| Last Verified: | October 2015 |
Keywords provided by Takeda:
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Liver resection Liver transplantation Liver surgery Secondary hemostasis |
Additional relevant MeSH terms:
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Hemorrhage Pathologic Processes |