Clinical trials: Intraoperative Complication
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
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Hemorrhage, Surgical, Hemorrhage Postoperative
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Trial name
- STAR-D (NCT05093504)
- Testing
- DrugSorb-ATR system
- Where
- 27 sites in United States
- Volunteers
- 9 people
- Sponsor
- CytoSorbents, Inc
Surgical Hemorrhage
A Phase III Study of Hemofence for Hemostasis in Patients With Uncontrolled Exudative Hemorrhage During Spinal Or Orthopedic Surgery
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that…
- Trial name
- NCT07824024
- Testing
- Hemofence, Floseal hemostatic matrix
- Where
- 3 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- BMI Korea
Blood Loss, Surgical
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the…
- Trial name
- NCT00448864
- Testing
- Ecallantide
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Postoperative Complications, Memory Disorders
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic…
- Trial name
- NCT00736125
- Testing
- pulsatile saline lavage, carbon dioxide lavage
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Kinamed Incorporated
Kidney Transplant
Kidney Protective Jacket
This is a safety study designed to investigate the safety of utilizing the Kidney Protective Jacket (KPJ)™ during kidney transplantation.
- Trial name
- KPJ (NCT07348458)
- Testing
- Kidney Protective Jacket
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- iiShield
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.
Coagulation Protein Disorders, Blood Loss, Surgical
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).
- Conditions
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- Trial name
- NCT01053169
- Testing
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Where
- 6 sites in United Kingdom
- Volunteers
- 445 people
- Sponsor
- CSL Behring
Blood Loss, Surgical
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
- Trial name
- NCT00306137
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 21 sites in United States, Australia and 8 more
- Volunteers
- 104 people
- Sponsor
- Bayer
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Respiratory Aspiration
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from…
- Trial name
- NCT01539135
- Testing
- Methylene Blue
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medtronic - MITG
Blood Loss, Surgical, Postoperative Hemorrhage
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7…
- Trial name
- NCT00327379
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 14 sites in Canada, Germany and 1 more
- Volunteers
- 54 people
- Sponsor
- Bayer
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.
Renal Tumors
Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors.
- Trial name
- NCT01104389
- Testing
- Fluorescence imaging
- Where
- United States
- Sponsor
- Intuitive Surgical
Blood Loss, Surgical
Observational Cohort Study of TachoSil (TC-018-IN)
The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.
- Trial name
- NCT00285623
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Nycomed
Hemorrhage, Surgical, Hemorrhage Postoperative
Safe and Timely Antithrombotic Removal (STAR) Registry
This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Trial name
- NCT05077124
- Testing
- CytoSorb
- Where
- 29 sites in Austria, Belgium and 4 more
- Volunteers
- 1,000 people
- Sponsor
- CytoSorbents, Inc
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.
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
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC