Clinical trials: Acute Bleeding
Acute Major Bleeding, Reversal of Coagulopathy
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who…
- Trial name
- NCT02281201
- Testing
- BE1116 (Prothrombin Complex Concentrate)
- Where
- 11 sites in Japan
- Volunteers
- 11 people
- Sponsor
- CSL Behring
Upper Gastrointestinal Bleeding
Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients
- Trial name
- NCT01155401
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
Hypovolaemia Due to Acute Blood Loss
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.
- Trial name
- PHOENICS (NCT03278548)
- Testing
- Volulyte 6%, Ionolyte
- Where
- 61 sites in Austria, Belgium and 8 more
- Volunteers
- 2,289 people
- Sponsor
- Fresenius Kabi
Acute Coronary Syndrome
A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in combination with standard…
- Trial name
- NCT00852397
- Testing
- Apixaban
- Where
- 18 sites in Japan
- Volunteers
- 151 people
- Sponsor
- Pfizer
Acute Coronary Syndrome, High Bleeding Risk
LEADERS FREE II: BioFreedom™ Pivotal Study
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
- Trial name
- NCT02843633
- Testing
- BioFreedom™ Drug Coated Coronary Stent System, Antiplatelet Drug
- Where
- 66 sites in United States, Canada and 5 more
- Volunteers
- 1,203 people
- Sponsor
- Biosensors Europe SA
Hemorrhage, Gastrointestinal Hemorrhage
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works…
- Conditions
- Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis, Postpartum Hemorrhage
- Trial name
- HEAL (NCT07753005)
- Testing
- Embolization therapy
- Where
- 11 sites in Japan
- Volunteers
- 176 people
- Sponsor
- Aesculap AG
Gastrointestinal Hemorrhage
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding
- Trial name
- NCT00402259
- Testing
- Esomeprazole IV, Omeprazole IV
- Where
- 7 sites in China
- Volunteers
- 440 people
- Sponsor
- AstraZeneca
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
Traumatic Injury
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have…
- Trial name
- NCT05568888
- Testing
- BE1116
- Where
- 113 sites in United States, Australia and 1 more
- Volunteers
- 1,366 people
- Sponsor
- CSL Behring
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Congenital Afibrinogenemia, Hypofibrinogenemia
FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis
This is a phase 3, multi-center, prospective, open-label, single-arm, clinical trial to be carried out in subjects with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia.
- Trial name
- NCT04636268
- Testing
- FIB Grifols
- Sponsor
- Instituto Grifols, S.A.
Acute Gastrointestinal Bleeding
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute…
- Trial name
- TREET (NCT06188585)
- Testing
- UI-EWD, Conventional therapy
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 278 people
- Sponsor
- Medtronic - MITG
Hemorrhage
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute) Evaluation of TachoSil in laparoscopic cholecystectomy Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy…
- Trial name
- NCT00546169
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 500 people
- Sponsor
- Nycomed
Multiple Myeloma, Myelodysplastic Syndromes
A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. 1.
- Trial name
- NCT02921802
- Where
- Japan
- Volunteers
- 4,626 people
- Sponsor
- Celgene
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.
- Trial name
- NCT00426803
- Testing
- activated recombinant human factor VII
- Where
- 15 sites in Australia, Austria and 13 more
- Volunteers
- 400 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth…
- Trial name
- NCT01563445
- Testing
- activated recombinant human factor VII
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Acute Major Bleeding
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate…
- Trial name
- NCT04867837
- Testing
- Octaplex
- Where
- 63 sites in United States, Austria and 11 more
- Volunteers
- 100 people
- Sponsor
- Octapharma
Acute Ischemic Stroke
Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.
- Trial name
- RAISE (NCT06226805)
- Testing
- BB-031
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 228 people
- Sponsor
- Basking Biosciences, Inc.
Intracerebral Hemorrhage, Stroke, Acute
A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
The purpose of this research study is to find out whether a device for monitoring bleeding in patients with acute hemorrhagic stroke will show similar findings as CT scans performed to evaluate the stroke.
- Conditions
- Intracerebral Hemorrhage, Stroke, Acute, Stroke Hemorrhagic
- Trial name
- NCT03038087
- Testing
- SENSE Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sense Diagnostics, LLC
Intracerebral Hemorrhage
A Proof of Concept Study to Evaluate CN-105 in ICH Patients
A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of symptom onset.
- Trial name
- CATCH (NCT03168581)
- Testing
- CN-105
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- AegisCN LLC