Clinical trials: Open Surgery
Hemostasis
Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
- Trial name
- NCT02014402
- Testing
- Human thrombin, Bovine thrombin
- Where
- 20 sites in United States
- Volunteers
- 181 people
- Sponsor
- Instituto Grifols, S.A.
Appendicitis
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.
- Trial name
- NCT01738750
- Testing
- Cost Information Included
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Utah
Open-heart Surgery, Cardiopulmonary Bypass
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe.
- Trial name
- NCT00569855
- Testing
- Phenoxybenzamine
- Where
- United States
- Volunteers
- 785 people
- Sponsor
- University of Arkansas
Moderate to Severe Acute Postoperative Pain
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within…
- Trial name
- NCT02221674
- Testing
- Tapentadol
- Where
- 7 sites in United States, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Grünenthal GmbH
Hemophilia A
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.
- Trial name
- NCT01913405
- Testing
- PEGylated Recombinant factor VIII (rFVIII)
- Where
- 22 sites in United States, Bulgaria and 7 more
- Volunteers
- 30 people
- Sponsor
- Baxalta now part of Shire
Hemostasis
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for…
- Trial name
- NCT03932240
- Testing
- Fibrinogen Concentrate (FC), Cryoprecipitate
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Hemophilia A
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion…
- Trial name
- NCT00243659
- Testing
- ReFacto AF
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Atelectasis, Pulmonary Infection
Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo…
- Conditions
- Atelectasis, Pulmonary Infection, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease
- Trial name
- NCT03438383
- Testing
- Bi-PAP
- Volunteers
- 48 people
- Sponsor
- Evangelismos Hospital
Post-Operative Pain, Acute Pain
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.
- Trial name
- NCT02687451
- Testing
- Oxymorphone HCl
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pain, Postoperative
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to…
- Trial name
- NCT02424578
- Testing
- Diclofenac Capsules low dose, Diclofenac Capsules high dose
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Iroko Pharmaceuticals, LLC
Lung Cancer
Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer
The goal of this clinical research study is to learn about the safety and effectiveness of OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery in the treatment of non-small cell lung…
- Trial name
- NCT00063258
- Testing
- Tarceva (OSI-774), Paclitaxel, Carboplatin
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- M.D. Anderson Cancer Center
ATIII Deficiency
Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery
The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the…
- Trial name
- NCT02103114
- Testing
- Anti-thrombin III
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Duke University
Congenital Fibrinogen Deficiency
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT02267226
- Testing
- Octafibrin
- Where
- 12 sites in United States, Bulgaria and 7 more
- Volunteers
- 25 people
- Sponsor
- Octapharma
Parenchymous Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the…
- Trial name
- NCT01754480
- Testing
- Fibrin Sealant Grifols, Surgicel®
- Where
- 33 sites in United States, Hungary and 2 more
- Volunteers
- 325 people
- Sponsor
- Instituto Grifols, S.A.
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Hemophilia A
BAX 802 in CHA With Inhibitors
The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.
- Trial name
- CHAWI (NCT02895945)
- Testing
- Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)
- Where
- 24 sites in United States, Bulgaria and 10 more
- Volunteers
- 8 people
- Sponsor
- Baxalta now part of Shire
Soft Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present.
- Trial name
- NCT01731938
- Testing
- Fibrin Sealant (FS) Grifols, Surgicel®
- Where
- 25 sites in United States, Hungary and 1 more
- Volunteers
- 327 people
- Sponsor
- Grifols Biologicals, LLC
Malignant Melanoma
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric…
- Trial name
- NCT01519323
- Testing
- vemurafenib
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche