Clinical trials: Bleeding Cardiac Surgery Patients
Central Venous Catheterization
Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance
Ultrasound-guided axillary vein catheterization can be performed via the proximal or distal approach of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches…
- Trial name
- NCT03395691
- Testing
- The distal approach, The proximal approach
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Shanghai Zhongshan Hospital
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, Platelets; Defect
Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients
This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients…
- Conditions
- Hemorrhage, Platelets; Defect, Bleeding, Surgical Blood Loss
- Trial name
- CHASE (NCT05220787)
- Testing
- Cold stored platelets in 100% plasma stored for 10-14 days, Room temperature stored platelets in 100% plasma stored for up to 7 days
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Moritz Stolla, MD
Coronary Artery Disease, Anemia
Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of MUF
It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass will result in improved patient outcomes over the 12-hour post-operative period as compared to control and off-line MUFF.
- Trial name
- MUF (NCT01864395)
- Testing
- Centrifugation Method, Online MUF, Offline MUF
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Saskatchewan
Coronary Surgery, Hemorrhage
Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding in Coronary Surgical Patients
Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary syndromes. Although the maintenance of aspirin until surgery does not affect postoperative bleeding after coronary artery bypass graft (CABG)…
- Trial name
- ICARE (NCT01216150)
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
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
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
Congestive Heart Failure
The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices
The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery.
- Trial name
- NCT01481012
- Where
- 13 sites in United States
- Volunteers
- 94 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Atrial Fibrillation (AF), VTE
Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure
PAUSE 2 study is a prospective, open-label, blinded-endpoint non-inferiority RCT of PAUSE vs. ASRA management in DOAC treated high risk patients with AF/VTE who need elective high bleed risk surgery/procedure and/or any procedure…
- Trial name
- PAUSE 2 RCT (NCT06957366)
- Testing
- PAUSE Perioperative DOAC Management, ASRA Perioperative DOAC Management
- Where
- 14 sites in United States, Belgium and 2 more
- Volunteers
- 920 people
- Sponsor
- McMaster University
Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks
Transfusion Reduction in High-Bleeding-Risk Cardiac Surgery With Desmopressin
Rationale Bleeding after cardiac surgery is a complication that might result in increased morbidity, mortality, and cost of cardiac surgery by 1.76 (confidence interval (CI), 1.64-1.90) times and a median increase in costs by…
- Conditions
- Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks, Planned Elective Cardiac Surgery Using CPB
- Trial name
- REDES-BLEED (NCT07012837)
- Testing
- Desmopresin
- Where
- Saudi Arabia
- Volunteers
- 112 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
Chronic Subdural Hematoma, Anticoagulant-induced Bleeding
Management of Anticoagulants and Antithrombotics in Patients With CSDH
Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular…
- Conditions
- Chronic Subdural Hematoma, Anticoagulant-induced Bleeding, Thromboembolic Stroke, Cardiovascular Stroke
- Trial name
- THERCA (NCT05079295)
- Testing
- CSDH evacuation
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- University Hospital of Ferrara
Bleeding
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac…
- Trial name
- NCT01530399
- Testing
- MDCO 1, MDCO 2, MDCO 3
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 44 people
- Sponsor
- The Medicines Company
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
General Surgery, Blood Loss, Surgical
Intraoperative Estimated Blood Loss, Blood Transfusion, and Postoperative Clinical Outcomes in Patients Undergoing Non Cardiac Surgery, Siriraj Hospital
After review literature, Siriraj hospital has not unanimous protocol to guide proper preoperative anemia and blood transfusion. This retrospective study will review non-cardiac surgery cases and collect data such as demographic…
- Trial name
- NCT05430659
- Testing
- observational study
- Where
- Thailand
- Volunteers
- 1,268 people
- Sponsor
- Siriraj Hospital
Post Cardiac Surgery Systemic Inflammatory Response
Single Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac Surgery
Protocol Summary STUDY DESIGN A pilot, prospective, double blind, randomized, placebo controlled study. STUDY POPULATION Patients assigned to elective CABG with cardiopulmonary bypass (CPB) at the Department of Cardiothoracic…
- Trial name
- NCT02191839
- Testing
- Alpha 1-Antitrypsin
- Volunteers
- 20 people
- Sponsor
- Soroka University Medical Center
Blood Loss, Surgical, Ticagrelor
Comparison of CABG Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel
In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and a P2Y12-receptor antagonist) is a commonly used method because of its excellent antithrombotic effect.
- Conditions
- Blood Loss, Surgical, Ticagrelor, Clopidogrel
- Trial name
- CABG (NCT04431349)
- Testing
- Ticagrelor 180mg, Clopidogrel 75mg
- Where
- South Korea
- Volunteers
- 1,097 people
- Sponsor
- Ajou University School of Medicine
Hemorrhage, Cerebrovascular Accident
Antiplatelet Therapy Continuation in Spine Surgery - Its Effect on Postoperative Morbidity and Mortality
The objective of this study is to evaluate the safety of antiplatelet (APA)therapy continuation in patients undergoing lumbar spine surgery (laminectomy, discectomy and foraminotomy), and to gather evidence-based data regarding…
- Conditions
- Hemorrhage, Cerebrovascular Accident, Myocardial Infarction, Pulmonary Embolism
- Trial name
- NCT01006083
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Blood Coagulation Disorder, Postoperative Blood Loss
Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion.
- Conditions
- Blood Coagulation Disorder, Postoperative Blood Loss, Adverse Drug Event, Fibrinolysis; Hemorrhage
- Trial name
- NCT07164300
- Testing
- Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h, Tranexamic acid at a dose of 20 mg/kg, Tranexamic acid at a dose of 30 mg/kg
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- University of Ioannina
Thrombosis, Cancer
Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)
The purpose of this study is to help find how safe current practices are when managing blood thinners in people with cancer who are having surgery or medical procedures.
- Conditions
- Thrombosis, Cancer, Thrombosis, Deep Vein, Atrial Fibrillation (AF)
- Trial name
- ACE-HIGH (NCT07372716)
- Testing
- standardized perioperative anticoagulation management Guideline
- Where
- Canada
- Volunteers
- 700 people
- Sponsor
- Ottawa Hospital Research Institute
Patient Care Team, Coronary Artery Disease
Developing an Intervention to Improve the Non-Technical Skills of the Cardiac Surgical Teams
Teams of several medical professionals conduct high-risk cardiac surgical procedures. These professionals work in complex, stressful operating room environments requiring effective communication and teamwork skills.
- Conditions
- Patient Care Team, Coronary Artery Disease, Coronary Artery Bypass, Surgery
- Trial name
- NCT06257511
- Testing
- Simulation-Based Mastery Learning of the Non-technical skills
- Volunteers
- healthy volunteers welcome
- Sponsor
- Northwestern University