Phase 3
Completed N=253
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
Source: ClinicalTrials.gov NCT01192022 ↗Enrolled (actual)
253
Serious AEs
45.2%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes — 80.7; 50.0; 87.5; 44.4 percentage of participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes |
80.7; 50.0; 87.5; 44.4; 83.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes |
94.7; 76.4; 87.5; 77.8; 100.00 | — |
| SECONDARY Time to Intraoperative Hemostasis at Target Bleeding Site |
3.0; 3.0; 3.0; 3.5; 3.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01192022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.