Symptoms and General Pathology

All Conditions

Postoperative Complications

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Hematinics

Coagulants

Epinephrine

Liver Extracts

Hemostatics

Racepinephrine

Epinephryl borate

Hemopatch is applied upon the verification made by the surgeon of the presence of an appropriate target bleeding site in the hepatic parenchyma. At the time point of application a stopwatch starts simultaneously. Time to hemostasis is defined as the time required to obtain successful haemostasis in a single bleeding site. At 3 minutes the inspection will be made and, if haemostasis is not achieved, the treatment is considered failed and the Principal Investigator and/or his delegates is allowed to use additional haemostatic measures.The time to haemostasis will be recorded in the patient's medical record and in the electronic Case Report Form. The bleeding site will be observed for 1 additional minute at the end of the haemostatic procedure and, of the surgery to confirm the haemostasis.

Hemopatch

Patients undergoing liver resection for any underlying disease and with resectable mass. The list of the underlying diseases is the following (but might not be limited to): Hepatocellular carcinoma, Hilar cholangiocarcinoma, Adrenal cancer metastasis, Breast cancer metastasis, Colorectal cancer metastasis, Ovarian cancer metastasis, Biliary carcinoma, Hemangioma, Hepatic adenoma, Focal nodular hyperplasia, Unilocular hydatid cyst, Multilocular, hydatid cyst.

Common Surgical Techniques

Pacelli

Fabio FP Pacelli, MD

* Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen.
* Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries.
* In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture.

These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.

Advances in surgical techniques have reduced the occurrence of postoperative complications following liver resection and resulted in low surgical mortality and morbidity rates in high-volume centers.

Although partial liver resections for primary or secondary hepatic malignancies are considered standard interventions, intraoperative blood loss remains a risk factor associated with major complications in liver surgery \[1-3\]. There are several methods for reduction of blood loss, including meticulous resection technique along anatomical planes, reduction of central venous pressure during transection of the liver parenchyma \[4\], and vascular occlusion techniques (i.e., inflow occlusion and total vascular occlusion) \[5-7\]. In addition, specific instruments were devised for liver transection, such as the ultrasonic dissector, water jet, and other, more recent developments (e.g., focal radiofrequency ablation) that allow sealing of small vessels during transection \[8, 9\].

In order to control diffuse bleeding and to prevent intraperitoneal complications attributed to bleeding, various topical products are used when the conventional methods, such as suture, ligation, or argon beam coagulation, fail. Currently, there are numerous products on the market which are promising a successful outcome for hemostasis. These products include gelatin, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues.

Efficacy and Tolerability of Hemopatch After Hepatic Resection

Exploratory Phase IV Randomized Single Blind Study Evaluating the Efficacy and Tolerability of Hemopatch in Improving Time of Hemostasis and Preventing Post-operative Complications After Hepatic Resection

Evaluation of the improvement of the time of hemostasis

measurement of glucose, urea nitrogen, creatinine, sodium, potassium, calcium, total cholesterol, High Density Lipid and Low Density Lipid, triglyceride, alkaline phosphatase, Lactate Dehydrogenase, complete blood cell counts with differential and platelet counts, activated partial thromboplastin time, Prothrombin, international normalized ratio, fibrinogen, erythrocyte sedimentation rate, C-reactive Protein and Liver function tests, such as Alanine Transferase, Aspartate Transferase, Alkaline Phosphatase, bilirubin and total protein, gamma-glutamyl transferase

measurement of drain pigmentation, i.e.biliary bloody clear

Evaluation of the hepatic parenchyma characteristics, intraoperative measurement of total volume of transfused blood products, type of the hepatic resection, the estimated intraoperative blood loss, the use of Pringle's maneuver

Baxter Healthcare Corporation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Heart and Blood Diseases

Neoplasms

Thrombosis

Head and Neck Neoplasms

Ischemia

Reperfusion Injury

Central Nervous System Depressants

Anesthetics

Four 5-minute cycles of upper extremity ischemia, each separated by five minutes of reperfusion. The treatment will be carried out with a tourniquet inflated to 200 mmHg during general anaesthesia prior to flap ischemia and transfer.

The tourniquet will be attached to the patient's upper extremity but never inflated.

Remote ischemic preconditioning

Sham

Anne-Mette Hvas, M.D., Ph.D.

The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer.

Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet.

Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation.

Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography.

Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.

Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial

Aarhus University Hospital Skejby

M.D.

Nervous System Diseases

Rare Diseases

Brain Neoplasms

Meningioma

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Thrombin

Fibrin Tissue Adhesive

Standard of Care (SoC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Bioseal Fibrin Sealant

Standard of Care (SoC)

Richard Kocharian, MD, PhD

The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.

Phase IV Bioseal Study in Brain Tumor Surgery

A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery

The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.

The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS.

Guangzhou Bioseal Biotechnology Co., Ltd.

Ethicon, Inc.

Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.

Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH). Standard of Care (SoC)

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Bioseal Fibrin Sealant

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Height

Weight

Underweight

Normal

Overweight

Obese

BMI Group

Current Smoker

Former Smoker

Never Smoked

Smoking Status

Adult subjects between the ages of 18 and 75 years were eligible for recruitment into the study.Subject 16225 was enrolled at age 12 and did not match the study inclusion/exclusion criteria. This was logged as a protocol deviation.

Senior Director of Ethicon Clinical R&D

H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application

Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.

Hemostasis at the TBS at 3 Minutes Following Treatment Application

Neurosurgical Complication

Unplanned Intervention

Central Nervous System

Surgical Wound Complication

Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.

Incidence of Potential Bleeding-related Adverse Events

SoC include Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).

Overall Study

Skin and Connective Tissue Diseases

Leiomyoma

Hemorrhage

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

Pharmaceutical Solutions

Natriuretic Agents

Amino Acids

Vasopressins

Arginine Vasopressin

Arginine

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.

Vasopressin

Hee Seung Kim, MD/PhD

The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.

This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study.

Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.

Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study

The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle

Time from anesthesia start to delivery of patient to recovery room

Whether patients are transfused during admission period Number of units transfused red blood cell

The amount of fluid injected during operation

CHA University

Seoul National University Hospital

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery

Bipolar electrocauterization during surgery Drug(-)

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Surgiguard

The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy

In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination

PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

ovarian volume measured by ultrasonography

Associate Professor, Department of Obstetrics & Gynecology

Blood and Lymph Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Patients with acute myeloid leukemia, associated to hyper leukocytosis

Patients with acute myeloid leukemia, without hyper leukocytosis

Hyper-leukocytosis \> 50.109/L is observed in 15% of acute myeloid leukemia (AML).

Level of hyper-leukocytosis is linearly associated with the incidence of life threatening complications that lead to the early death in 25% of these patients.

The HEAL project is a prospective, uni-centric, observational study that plans to include a cohort of 50 patients presenting de novo AML with hyper-leukocytosis (HL) (\> 50.109/L) and 10 controls. The aim of the study is to describe the relative proportion of various hemostasis components disturbances, endothelium alterations, platelet dysfunction and to calculate cumulative incidence of hemorrhagic and thrombotic complications as well as overall survival of patients presenting with HL AML.

Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia

Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia

plasma concentration of Fragments thrombin 1+2

plasma concentration of plasmin-antiplasmin complex

plasma concentration of t-PA-PAI-1 complex

Activated Partial Thromboplastin Time \[APTT\]

Time from inclusion to first serious bleeding event

Time from inclusion to first thrombotic event

Time from inclusion to death of any cause

duration of stay in ICU within the first month

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Tolerability of Hemopatch After Hepatic Resection	NCT03323359	Hepatectomy Cancer, Metasta... Hemostasis	Hemopatch Common Surgical...	18 Years - 75 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial	NCT02548377	Head and Neck N...	Remote ischemic... Sham	18 Years -	Aarhus University Hospital Skejby
Phase IV Bioseal Study in Brain Tumor Surgery	NCT02034799	Hemostasis Meningioma Surg...	Bioseal Fibrin ... Standard of Car...	18 Years - 75 Years	Ethicon, Inc.
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy	NCT04874246	Uterine Leiomyo...	Vasopressin	19 Years - 60 Years	Seoul National University Hospital
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy	NCT03374397	Ovarian Cyst Be...	Surgiguard	18 Years - 45 Years	Seoul National University Hospital
Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia	NCT04133220	Leukemia, Myelo...		18 Years - 65 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for hemostasis

Every month we try and update this database with for hemostasis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hemostasis

Every month we try and update this database with for hemostasis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hemostasis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.