Clinical trials: Major Surgery
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery.
- Trial name
- NCT01127477
- Testing
- 1: Hydroxyethyl starch 130/0.4, 6 %
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Fresenius Kabi Japan
Hypovolemia
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major…
- Trial name
- NCT01531803
- Testing
- Kedbumin 25%, Normal Saline Solution
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kedrion S.p.A.
Post Operative Pain, Acute
A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in…
- Trial name
- NCT07225140
- Testing
- Combogesic® tablets, Acetaminophen 500mg
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Hemophilia A
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery
The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.
- Trial name
- NO PEACKS (NCT00922597)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 7 sites in Austria, Germany and 5 more
- Volunteers
- 26 people
- Sponsor
- Bayer
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
Major Depressive Disorder, MDD
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
The goal of this observational study is to record and analyze factors putatively affecting the clinical outcomes among patients undergoing transcranial magnetic stimulation (TMS) treatment for major depressive disorder (MDD) or…
- Conditions
- Major Depressive Disorder, MDD, Generalized Anxiety Disorder, GAD
- Trial name
- OBSERVER (NCT06512324)
- Testing
- Ampa One TMS System
- Where
- 2 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Biomedical Discoveries and Neuroscientific Foundations LLC
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Hemophilia A
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local…
- Trial name
- NCT00092976
- Testing
- ReFacto
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Pain
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib
This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.
- Trial name
- NCT00348491
- Testing
- Lumiracoxib
- Where
- United States
- Volunteers
- 364 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01561391
- Testing
- activated recombinant human factor VII, factor IX, factor VIII
- Where
- 14 sites in United States
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
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
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
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
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
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
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
Prevent Bleeding in Major Surgery
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
- Trial name
- WONDERS (NCT01365546)
- Testing
- human VWF/FVIII concentrate
- Where
- 15 sites in United States, Bulgaria and 7 more
- Volunteers
- 30 people
- Sponsor
- Octapharma
Hemophilia B
BAX 326 Surgery Study in Hemophilia B Patients
The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B undergoing major or minor elective or emergency…
- Trial name
- NCT01507896
- Testing
- Recombinant factor IX
- Where
- 14 sites in Argentina, Bulgaria and 8 more
- Volunteers
- 30 people
- Sponsor
- Baxalta now part of Shire
Hemophilia
BAY14-2222 Continuous Infusion in Surgeries
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
- Trial name
- NCT00606060
- Testing
- Kogenate (BAY14-2222)
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Bayer
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences