Clinical trials: Surgery, Cardiovascular
Surgical Blood Loss, Postoperative Blood Loss
Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated.
- Trial name
- REPLACE (NCT01475669)
- Testing
- Fibrinogen Concentrate (Human) (FCH)
- Where
- 35 sites in Austria, Brazil and 9 more
- Volunteers
- 152 people
- Sponsor
- CSL Behring
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE
- Trial name
- NCT00846807
- Where
- 112 sites in Austria, France and 7 more
- Volunteers
- 5,476 people
- Sponsor
- Boehringer Ingelheim
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Venous Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective knee replacement surgery.
- Trial name
- SAVE-KNEE (NCT00718224)
- Testing
- Semuloparin sodium, Enoxaparin
- Where
- 17 sites in United States, Argentina and 15 more
- Volunteers
- 1,150 people
- Sponsor
- Sanofi
Abdominal Aortic Aneurysm, Morbid Obesity
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on…
- Trial name
- SSIHLVER (NCT06547138)
- Testing
- Prophylactic mesh
- Where
- 5 sites in Spain
- Volunteers
- 110 people
- Sponsor
- Aesculap AG
Blood Pressure, Heart Diseases
Comparison of the Non-invasive Biobeat Device With an Invasive Arterial Line
In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, continuous and wireless Biobeat monitoring device (a wrist watch or a patch configuration) to an invasive arterial…
- Trial name
- NCT03603860
- Testing
- Non-invasive monitoring
- Where
- Israel
- Volunteers
- 18 people
- Sponsor
- Biobeat Technologies Ltd.
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
Type 2 Diabetes, Cardiovascular Disease
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2.
- Trial name
- DSS (NCT00641251)
- Testing
- intensive medical management, RYGB & IMM
- Where
- 5 sites in United States, Taiwan
- Volunteers
- 120 people
- Sponsor
- Medtronic - MITG
Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require…
- Trial name
- FCAD02 (NCT00838383)
- Testing
- sitaxsentan (Thelin)
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Pfizer
Coagulation; Intravascular, Fluid Electrolyte Disorders
Effect of Human Plasma Protein Transfusion With and Without Crystalloids During Major Liver Resection Surgeries
Evaluation of acid-base and electrolyte changes after administration of commonly used colloid solutions (plasma protein fraction contains 5% albumin), and crystalloids (saline 0.9% and lactated ringers solutions) is the primary…
- Trial name
- NCT05033704
- Testing
- 5% human plasma protein fraction (PPF)
- Where
- Qatar
- Volunteers
- 48 people
- Sponsor
- Hamad Medical Corporation
Venous Thromboembolism
Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty
The main goal is to provide additional information to the risk-benefit assessment of the drug.
- Trial name
- XAMOS (NCT00831714)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard care treatment for VTE prophylaxis
- Where
- 42 sites in Australia, Austria and 40 more
- Volunteers
- 19,076 people
- Sponsor
- Bayer
Acute Kidney Injury, Abdominal Compartment Syndrome
Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients.
- Conditions
- Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension, Cardiovascular Surgery
- Trial name
- NCT04585555
- Testing
- Accuryn Monitoring System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Potrero Medical
Surgical Site Infection, Thrombosis
Tumescent Anesthesia Antibiotic Delivery (TAAD)
This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food \& Drug Administration (FDA) has approved our…
- Conditions
- Surgical Site Infection, Thrombosis, Sepsis
- Trial name
- TAAD (NCT03226626)
- Testing
- Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD, SubQKath
- Volunteers
- 330 people
- Sponsor
- HK Surgical, Inc.
Injury of Kidney, Acute Renal Failure
A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 8-10 centers in the United States and Switzerland.
- Trial name
- NCT00554359
- Testing
- I5NP (a small interfering RNA)
- Where
- 11 sites in United States, Israel and 1 more
- Volunteers
- 16 people
- Sponsor
- Quark Pharmaceuticals
Aortic Valve Stenosis
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV…
- Trial name
- REDO (NCT01051310)
- Testing
- Medtronic CoreValve System
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 18 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sudden Cardiac Death, Ventricular Fibrillation
LifeVest Post-CABG Registry
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease…
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction
- Trial name
- NCT01448005
- Testing
- wearable defibrillator (LifeVest)
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Zoll Medical Corporation
Thrombus, Embolus
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
- Conditions
- Thrombus, Embolus, Occlusion; Vessel
- Trial name
- OTW (NCT05386342)
- Testing
- TufTex Over-the-Wire Embolectomy Catheter
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 112 people
- Sponsor
- LeMaitre Vascular
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Atrial Fibrillation
Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System…
- Trial name
- CURE-AF/Perst (NCT00506493)
- Testing
- Cardioblate Surgical Ablation System, Surgical RF Ablation
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Medtronic Cardiac Surgery