Clinical trials: Intraoperative Complication
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
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
Postoperative Pain
A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.
- Trial name
- TKA (NCT00745290)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 19 sites in United States
- Volunteers
- 245 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hypovolemia, Hemorrhage
Trial of 6% HES130/0.4
The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of…
- Trial name
- NCT01010022
- Testing
- 6% hydroxyethyl starch 130/0.4, 6% hydroxyethyl starch 70/0.5 (Salinhes®)
- Where
- 7 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Fresenius Kabi Japan
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
Blood Loss, Surgical
QStat in Liver Transplant
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
- Trial name
- NCT04114253
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
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
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.
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
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
HemoSonics - UTMB Cardiac Surgery Study
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the…
- Trial name
- NCT03988465
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
Anemia, Blood Loss, Surgical
An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.
- Conditions
- Anemia, Blood Loss, Surgical, Neoplasms
- Trial name
- NCT00264095
- Testing
- Oncological surgery
- Where
- 11 sites in Netherlands
- Volunteers
- 488 people
- Sponsor
- Janssen-Cilag B.V.
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
Blood Loss, Surgical, Postoperative Hemorrhage
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.
- Trial name
- NCT00306150
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 37 sites in United States, Belgium and 5 more
- Volunteers
- 57 people
- Sponsor
- Bayer
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
Operative Hemorrhage
Intrauterine Use of FloSeal: Is it Safe and Useful?
When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the…
- Trial name
- NCT01746628
- Testing
- Hysterectomy with FloSeal
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- David L Zisow MD LLC
Ovarian Cancer
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval…
- Trial name
- NCT03180307
- Testing
- OTL38, near infrared camera imaging system, laparotomy
- Where
- 11 sites in United States, Netherlands
- Volunteers
- 140 people
- Sponsor
- On Target Laboratories, LLC
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
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
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.