Clinical trials: Intraoperative Complications
Blood Loss, Surgical, Coagulation Disorder
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that…
- Trial name
- EQUILIBRIX-S (NCT07288489)
- Testing
- Reltodecacog alfa, Usual Pharmacological Care
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 800 people
- Sponsor
- VarmX B.V.
Intraoperative Bleeding, Liver Diseases
GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery
This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for…
- Conditions
- Intraoperative Bleeding, Liver Diseases, Gallbladder Diseases, Hemorrhage, Surgical
- Trial name
- NCT05900037
- Testing
- GATT-Patch, SURGICEL® Original
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- GATT Technologies BV
Surgical Blood Loss, Surgical Complication
Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
The goal of this clinical trial is to evaluate the usability of the Haermonics Pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass.
- Trial name
- USEPURE (NCT06521164)
- Testing
- Haermonics Pure system
- Volunteers
- 65 people
- Sponsor
- Haermonics BV
Ovarian Cancer, Epithelial Ovarian Cancer
Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
- Trial name
- NCT00563836
- Testing
- Catumaxomab
- Where
- 2 sites in Austria, Germany
- Volunteers
- 41 people
- Sponsor
- Neovii Biotech
Postoperative Blood Loss
Effect of Early Administration of TXA in Adult Hip Fractures
This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center.
- Trial name
- NCT05047133
- Testing
- Tranexamic acid
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Ascension Health
Blood Loss, Surgical
Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
- Trial name
- NCT00307515
- Testing
- Fibrin Sealant 2 (FS2), Oxidized Regenerated Cellulose (Surgicel)
- Where
- 16 sites in United States
- Volunteers
- 135 people
- Sponsor
- Ethicon, Inc.
Gluteal Tissue Ischemia Risk, Foreign-Body Reaction
Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal
This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers.
- Conditions
- Gluteal Tissue Ischemia Risk, Foreign-Body Reaction, Soft Tissue Filler Complication
- Trial name
- NCT07808996
- Testing
- Preoperative MRI Morphometric Mapping, Standardized Intraoperative and Fresh-Specimen Measurement
- Volunteers
- 220 people
- Sponsor
- Research Inc
Intraoperative Complications
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven…
- Trial name
- NCT00308100
- Testing
- Hydroxyethylstarch 130/0.4, 5% Albumin
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fresenius Kabi
Astrocytoma, Brain Cancer
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers…
- Conditions
- Astrocytoma, Brain Cancer, Brain Metastases, Bladder Cancer
- Trial name
- NCT04430842
- Testing
- QBS10072S
- Where
- 2 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Quadriga Biosciences, Inc.
Blood Loss, Surgical
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.
- Trial name
- CLOT (NCT02359994)
- Testing
- PerClot Polysaccharide Hemostatic System, Arista AH
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Artivion Inc.
Urinary Incontinence, Erectile Dysfunction
Intraoperative Nerve Monitoring During Robot-assisted Laparoscopic Prostatectomy
The purpose of this study is to determine whether the use of intraoperative nerve monitoring during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary continence and erectile function.
- Trial name
- NCT02446808
- Testing
- Intraoperative nerve monitoring
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- ProPep Surgical, LLC
Intraoperative Bleeding, Hemorrhage, Surgical
GATT-Patch Versus TachoSil in Liver Surgery
This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with…
- Conditions
- Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
- Trial name
- NCT05385952
- Testing
- GATT-Patch (currently named ETHIZIA), TachoSil
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 132 people
- Sponsor
- GATT Technologies BV
Blood Loss, Surgical
Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and…
- Trial name
- NCT03152461
- Testing
- Quantra System
- Where
- 4 sites in United States
- Volunteers
- 302 people
- Sponsor
- HemoSonics LLC
Blood Loss, Surgical, Prostate Cancer
Safety Study of Hemospan® in Prostatectomy Patients
This is a progressive dose escalation study designed to evaluate the safety of Hemospan compared to a standard crystalloid solution (Ringer's lactate) in elective surgery patients undergoing total prostatectomy procedures with…
- Conditions
- Blood Loss, Surgical, Prostate Cancer, Surgery
- Trial name
- NCT00425334
- Testing
- Hemospan (MP4OX), Ringer's lactate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sangart
Blood Loss, Surgical
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery.
- Trial name
- NCT00668031
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 40 sites in United States, Canada and 1 more
- Volunteers
- 359 people
- Sponsor
- Bayer
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
Blood Loss, Surgical, Postoperative Hemorrhage
Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery.
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use…
- Trial name
- VYSIO-FEASIBIL (NCT07826637)
- Testing
- Wearable optical hemodynamic monitoring device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hemorai Inc
Blood Loss, Surgical, Hemostasis
OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)
OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques…
- Trial name
- NCT00279383
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 800 people
- Sponsor
- Nycomed
Kidney Cancer
A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy
This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for…
- Trial name
- NCT04329767
- Testing
- IRIS 1.0
- Where
- 2 sites in United States
- Volunteers
- 122 people
- Sponsor
- Intuitive Surgical
Blood Loss, Surgical, Blood Loss, Postoperative
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.
- Trial name
- NCT04656067
- Testing
- Oxytocin ,Tranexamic acid and Ethamsylate
- Where
- Egypt
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Egymedicalpedia