10 completed, 4 unknown, 1 terminated, 1 withdrawn. 5 Phase 2, 4 Not applicable, 3 Phase 3, 3 Phase 4, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 4, Unknown 1 |
| Not applicable | 4 | Completed 3, Terminated 1 |
| Phase 3 | 3 | Completed 2, Unknown 1 |
| Phase 4 | 3 | Unknown 2, Withdrawn 1 |
| Phase 1 | 1 | Unknown 1 |
Follow Tisseel: new trials by email Literature Review of Tisseel trials Research Report on Tisseel
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Fibrin Sealant in Eyelid Surgery Tisseel - Blepharoptosis, Ecchymosis; Eyelid | Phase 2 / Phase 3 | Unknown | University of Calgary | 30 | 2022-05-01 | 2022-05-03 |
| PEP on a Skin Graft Donor Site Wound 10% PEP, TISSEEL, 20% PEP - Skin Graft | Phase 1 | Unknown | Rion Inc. | 8 | 2021-03-16 | 2023-09-08 |
| Tisseel® as a Reinforcement of Esophagojejunal Anastomoses Tisseel, No Tisseel - Gastric Cancer, Anastomotic Leak | Phase 4 | Unknown | Germans Trias i Pujol Hospital | 146 | 2020-07-21 | 2020-07-23 |
| The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery Tisseel - Cleft Palate | Phase 4 | Withdrawn | University of Alberta | 2019-09-01 | 2022-05-20 | |
| A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment TISSEEL - Cerebrospinal Fluid Leaks | Phase 2 | Completed | Duke University | 15 | 2017-12-18 | 2021-06-18 |
| Reducing Blood Loss Using Tisseel in TKA Tisseel, Tranexamic Acid - Total Blood Loss | Phase 4 | Unknown | Chang Gung Memorial Hospital | 100 | 2017-11-01 | 2017-10-16 |
| Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery Spray Fibrin Sealant, Traditional Hemostasis and chest Closure Routine - Hemorrhage | Not applicable | Completed | Cardiochirurgia E.H. | 120 | 2017-02-02 | 2018-09-18 |
| Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery FS VH S/D 500 s-apr, DuraSeal Dural Sealant - Cerebrospinal Fluid Leak | Phase 3 | Completed | Baxter Healthcare Corporation | 224 | 2016-10-11 | 2019-09-10 |
| Efficiency of TISSEEL for Sleeve Gastrectomy Complications tisseel, no tisseel - Morbid Obesity | Phase 3 | Completed | Centre Hospitalier Universitaire, Amiens | 597 | 2014-02-01 | 2020-07-14 |
| Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation Fibrin Sealant, Tissue-penetrating mesh-fixation - Hernia, Inguinal, Recurrence | Completed | Herlev Hospital | 2340 | 2012-07-01 | 2015-03-18 | |
| Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection Fibrin Sealant (FS) VH S/D 500 s-apr, Manual compression - Bleeding (Oozing) in Hepatic Resection | Phase 2 | Completed | Baxter Healthcare Corporation | 70 | 2010-11-01 | 2013-02-20 |
| Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty Fibrinogen, Septorhinoplasty, Taping after septorhinoplasty. - Recovery Time, Bruising | Not applicable | Terminated | Mayo Clinic | 25 | 2008-07-01 | 2016-04-18 |
| Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) - Facial Rhytidectomy (Face-lift) | Phase 2 | Completed | Baxter Healthcare Corporation | 45 | 2008-06-01 | 2012-10-23 |
| Fibrin Sealant for the Sealing of Dura Sutures Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Standard of care - Pathological Processes in the Posterior Fossa, Dura Defects | Phase 2 | Completed | Baxter Healthcare Corporation | 95 | 2008-05-01 | 2013-06-27 |
| Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients Fibrin Sealant - Melanoma | Not applicable | Completed | M.D. Anderson Cancer Center | 53 | 2003-02-01 | 2012-08-02 |
| Fibrin Melanoma Axillary Node Study in Patients With Melanoma Fibrin Sealant - Melanoma | Not applicable | Completed | M.D. Anderson Cancer Center | 121 | 2002-05-15 | 2023-05-09 |
Cerebrospinal Fluid Leak (2) · Hemorrhage (2) · Melanoma (2) · Seroma (2) · Anastomotic Leak (1) · Blepharoptosis (1) · Chronic Pain (1) · Cleft Palate (1) · Contusions (1) · Ecchymosis (1) · Exsanguination (1) · Hernia, Inguinal (1) · Intracranial Hypotension (1) · Obesity (1) · Obesity, Morbid (1)
Baxter Healthcare Corporation (4) · M.D. Anderson Cancer Center (2) · Cardiochirurgia E.H. (1) · Centre Hospitalier Universitaire, Amiens (1) · Chang Gung Memorial Hospital (1) · Duke University (1) · Germans Trias i Pujol Hospital (1) · Herlev Hospital (1) · Mayo Clinic (1) · Rion Inc. (1) · University of Alberta (1) · University of Calgary (1)
United States (8) · Canada (2) · Germany (2) · Spain (2) · Czechia (1) · Denmark (1) · France (1) · Italy (1)
Andreas Q Fenger, Researcher (1) · Elisenda Garsot (1) · Guenter Zuelow, MD (1) · Jacob Rosenberg, professor (1) · Janice N. Cormier, MD (1) · Jaret L Olson, MD FRCSC (1) · Karim Punja, MD (1) · Michael Sabbah, MD (1) · Neel M Helvind, Researcher (1) · Oren Friedman, M.D. (1) · Paul F. Mansfield, MD (1) · Qing Li, MD, PhD (1) · Steve Z Abrams, MD (1)
PMID 18564433, PMID 23515377, PMID 30080735
2015 (1)