Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02014402 | Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery | PHASE2 | COMPLETED | 181 | — | — | Dec 1, 2013 | Nov 1, 2015 | Jun 14, 2017 | 20 | United States |
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
| Arm | Type | Description |
|---|---|---|
| IG1202-A (Vascular) | EXPERIMENTAL | - |
| IG1202-B (Hepatic) | EXPERIMENTAL | - |
| IG1202-C (Soft Tissue) | EXPERIMENTAL | - |
| IG1202-D (Spinal) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Human thrombin | BIOLOGICAL | Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges |
| Bovine thrombin | BIOLOGICAL | Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges |
Inclusion Criteria: * Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) ≥9.0 g/dL (deciliter) * Pre-operative (at Baseline Assessments Visit) fibrinogen level ≥150 mg/dL (functional method). * Required one of the following procedures: 1. An elective (non-emergency), open (non-laparo...