Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Infections

Rare Diseases

Hemorrhage

Liver Cirrhosis

Adenoma

Liver Diseases

Hepatitis A

Hepatitis

Liver Neoplasms

Primary Liver Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Hematinics

Liver Extracts

A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.

PeproStat

D Mirza, MBBS, MS, FRCS

The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection surgery.

PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

A Multi-centre, Open-label, Uncontrolled, First-in-Human Study to Evaluate the Safety and Tolerability and Explore the Efficacy of PeproStat in Gelita-Spon® Gelatin Sponge in Subjects Undergoing Open Liver Resection Surgery

Immunogenicity to be investigated using a specific antibody test which has been established but not yet validated.

Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).

Percentages of subjects who achieve haemostasis within 3, 5, 7 and 10 minutes following application for the first five subjects and at 1, 3, 5, 7 \& 10 minutes following application in subsequent subjects.

Percentage of subjects who do not achieve haemostasis within 10 minutes.

Administered dose of PeproStat determined by number of sponges administered to a single bleeding site.

Haemostatix Ltd

all adult patients operated at the Léon Bérard Centre for cancer surgery (excluding endoscopy, interventional radiology, brachytherapy, vascular access)

Data from patients who were transfused at the Centre Léon Bérard from the day of surgery to the 10th postoperative day will be analyzed.

Transfusion

Acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate.

The only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects.

Nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions.

Acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate.

The only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects (immunosuppression, increased rate of carcinological recurrence...).

Nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions.

The aim of this work is to collect and analyze the estimated bleeding and the hemoglobin level of patients who underwent an intermediate or major operation in the general block of the Centre Léon Bérard in 2021 and who were transfused within 10 days of this operation.

In the first stage of data analysis, the investigators will collect data related to perioperative transfusion currently performed at the Centre Léon Bérard (year 2021).

Then, a pharmacoeconomic analysis will be carried out with an evaluation of the cell salvage technique by mini-HTA (Health Technology Assessment) type (clinical benefit, patient safety, target population, robustness of clinical evidence, budgetary impact, amount of investment, impact in terms of human resources (training), efficiency) with the objective of helping the Centre Léon Bérard management to make a decision.

AutoTransfusion Versus TRAnsfusion in Cancer Surgery

Autotransfusion Versus Transfusion in Cancer Surgery

number of annual uses (at the Centre Léon Bérard in 2021) of the intraoperative blood recovery system in the indications validated by the French High Authority for Health

Pharmacoeconomic analysis will be performed with an evaluation of the Cell-Saver mini-Health Technology Assessment technique (clinical benefit, patient safety, target population, robustness of clinical evidence, budgetary impact, investment amount, impact in terms of human resources (training), efficiency)

Centre Leon Berard

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Lung Neoplasms

Lung Diseases

Communicable Diseases

Mycoses

Pulmonary Embolism

Embolism

Pneumonia

Fistula

Respiratory Tract Infections

Arteriovenous Fistula

Mycobacterium Infections

Bronchitis

Tuberculosis

Bronchiectasis

Respiratory Tract Diseases

Bronchial Diseases

Signs and Symptoms, Respiratory

Hemoptysis

Disease Attributes

Bacterial Infections

Gram-Positive Bacterial Infections

Bacterial Infections and Mycoses

Pathological Conditions, Anatomical

Thrombosis

Embolism and Thrombosis

Vascular Diseases

Lung Diseases, Obstructive

Congenital Abnormalities

Arteriovenous Malformations

Vascular Malformations

Cardiovascular Abnormalities

Vascular Fistula

Patients over 18 years of age presenting with hemoptysis at the Centre Hospitalier Universitaire de Sherbrooke (CHUS) between the periods of 2005 to 2010.

Brian Grondin-Beaudoin, MD

Matthieu Poirier, MD

Amelie Blanchard, MD

Brian Grodin-Beaudoin, MD

The study consist of a retrospective analysis of the etiologies, investigations and outcomes of patients presenting between 2005 to 2010 with hemoptysis in a North-American Tertiary center.

RATIONALE:

Hemoptysis, mild or massive, is worrisome for both patients and physicians. The management is different depending on the causes, which are not well defined for the North American population. Despite the fact that this symptom is commonly reported in clinic, there are only a few studies published on this subject in the North-American population. Tuberculosis was a frequent cause of hemoptysis described in populations overseas, which seems less prevalent in the investigators center.

Also, there are no known official guidelines regarding the investigation and management of hemoptysis. The investigators hypothesized that the use of modern technology in a North American population may result in different findings and provide a more accurate diagnostic approach.

Therefore, the study compares the different etiologies of hemoptysis and investigation modalities used in patients presenting in a North-American tertiary center.

METHOD:

The investigators did a retrospective analysis of medical chart from patients with hemoptysis who visited the investigators center between 2005 and 2010. Each visit has been reviewed individually to describe the characteristics of patients, etiologies of hemoptysis and investigation modalities used. All-cause mortality at 2 years was also recorded.

Descriptive statistical analyses will conducted on the data available.

Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis

Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis in a North-American Tertiary Center at the Beginning of the 21st Century

Defining the prevalence of pulmonary diseases by measuring the percentage of patients presenting with hemoptysis caused by lung cancer, bronchiectasis, pulmonary embolism, arteriovenous fistula, pneumonia, bronchitis, tuberculosis, mycosis, heart failure, pseudohemoptysis, cryptogenic and other causes.

Determining the sensitivity in obtaining the etiology of the hemoptysis episode of each diagnostic modality that follows : chest X-ray, chest CT-scan and CT-angiography, bronchoscopy, ventilation-perfusion with single-photon emission computed tomography and pulmonary angiography in the diagnosis of different etiologies of hemoptysis.

All-cause mortality at 2 years after the diagnosis of hemoptysis.

Determining the percentage of patients who : never smoked, is an active smoker, former smoker or unknown status.

Determining the average age of the enrolled patients.

Determining the percentage of each gender of the enrolled patients.

Determining the median of the international normalized ratio (INR).

Determining the median of the partial thromboplastin time (PTT).

Determining the average of the platelet count measured per microliter of blood.

Université de Sherbrooke

Medical Doctor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Coagulants

Fibrinolytic Agents

Amino Acids

Tranexamic Acid

Plasminogen

Fibrinolysin

Antifibrinolytic Agents

Hemostatics

Lysine

Tranexamic Acid (TXA): bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively

Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively

Placebo

Ali JENDOUBI

Transurethral resection of the prostate (TURP) represents the gold standard in the operative management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most important complications of urological endoscopic resections is intraoperative and postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury, fluid overload, increased costs and hospital length of stay.

Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery and orthopedic surgical procedures but few studies have assessed the efficacy of this antifibrinolytic agent in urological endoscopic procedures.

The investigators designed this double-blind, placebo controlled study evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in patients undergoing endoscopic surgery in urology.

Participants will be randomized into one of two study groups: Group TXA: intravenous tranexamic acid: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The study drug was prepared by an anesthesiologist not involved in the patient management and data collection. The anesthetic technique will be standardized. Serum hemoglobin was measured before and after surgery. The volume of the irrigation fluid, resected prostate weight and duration of resection were recorded.

Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology

Safety and Efficacy of Intravenous Tranexamic Acid in Reducing Blood Transfusion After Endoscopic Transurethral Resections in Urology: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

University Tunis El Manar

MD, Assistant Professor

Venous Thrombosis

Thromboembolism

Venous Thromboembolism

Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.

Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.

The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.

Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge

Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

G. d'Annunzio University

Principal Investigator

Blood and Lymph Conditions

Thrombocytopenia

Hematologic Neoplasms

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.

Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.

IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.

Tranexamic acid (TXA).

Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath

Zoe K McQuilten, MBBS PhD

Simon J Stanworth, DPhil FRCP FRCPath

Erica M Wood, MB BS, FRACP, FRCPA

The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo.

Patients with cancers of the blood often develop low blood cell counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). But recent studies have indicated that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is a type of drug that is called an antifibrinolytic. These drugs act to reduce the breakdown of clots formed in response to bleeding. These drugs have been used widely in both elective and emergency surgery and have been shown to decrease blood loss and the use of red cell transfusions. The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo. The investigators will measure the rates of bleeding daily using a short structured assessment of bleeding and will record the number of transfusions given to patients.

TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia

The datasets generated during and/or analysed during the current study will be available upon request from the NHSBT Clinical Trials Unit after de-identification (text, tables, figures and appendices) 9 months after publication and ending 5 years following article publication.

Measured by number of days that the patient's laboratory results indicate that the patient is thrombocytopenic.

Reasons for platelet and red cell transfusions as documented by clinician.

The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment.

A time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost.

Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.

Bleeding assessed using WHO bleeding criteria.

Measured by number of recorded platelet transfusions per patient.

Measured by number of recorded red cell transfusions per patient.

Measured by calculating number of patients surviving at least 30 days without a platelet transfusion.

Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion.

Measured by calculating number of clinically diagnosed thrombotic events from Treatment Day 1 i.e the first day that the investigational medicinal product (IMP) is administered, up to and including the next 120 days.

Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered.

Measured by calculating number of deaths in first 30 days and 120 days after Treatment Day 1 i.e the first day that the IMP is administered.

Measured by calculating number of deaths due to thrombosis during the first 120 days after Treatment Day 1 i.e the first day that the IMP is administered.

Measured by calculating number of deaths due to bleeding during the first 30 days

Measured by calculating the total number of SAE's reported from first administration of IMP.

National Health and Medical Research Council, Australia

Monash University

NHS Blood and Transplant

Gastrointestinal Hemorrhage

Gastrointestinal Diseases

patients with cancer who presented or were admitted in the emergency room, wards or intensive care units of the Cancer Institute of São Paulo (ICESP), with a recent episode of upper gastrointestinal bleeding.

Fauze Maluf-Filho, MD, PHD

This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.

Background: Cancer incidence is rising worldwide, therefore complications of this condition, such as bleeding, are also expected to be more frequently seen.

Tumoral bleeding is usually difficult to control and the bleeding episode may represent the end stage of the malignant disease. In this context, it is relevant to study the performance of prognostic scores to prediction of clinical outcomes in patients with cancer.

Objective: To evaluate and compare the performance of prognostic scores to predict clinical outcomes in a group of patients with cancer of any site that has presented a recent episode of upper gastrointestinal bleeding (UGIB).

Design: Prospective and observational study. Setting: Cancer Institute of São Paulo; University of são Paulo. Patients: All patients with cancer referred to the Endoscopy Unit because of upper gastrointestinal bleeding will be included consecutively.

Main Outcome Measurements: need and amount of blood transfusions administered, need for endoscopic therapy, surgery, rebleeding, and mortality at 30 days.

Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer

Comparison Among the Scores of Glasgow-Blacthford, Rockall and AIMS65 for the Prediction of Rebleeding and Mortality in Patients With Cancer and Upper Gastrointestinal Bleeding

The need and amount of blood transfusions administered

Hemostatic endoscopic therapy will be performed if there are findings of active or recent bleeding, under conscious or deep sedation after hemodynamic stabilization and oral fasting

need for surgery to control tumour bleeding

find the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores for discriminant selection of a low-risk group, if one exists, among patients with recent upper gastrointestinal bleeding and cancer with confirmed diagnosis, located inside or outside the GI tract, who could be managed on an outpatient basis.

Instituto do Cancer do Estado de São Paulo

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Triple tourniquet consist of two tourniquet applied both infundibulopelvic ligaments and one uterine isthmus to occlude the left and right ovarian vessels and to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.

Through the same openings in the broad ligament each side a Foley catheter looped around the infundibulopelvic ligament lateral to the fallopian tube and ovary.

triple tourniquet

Single tourniquet is tourniquet applied uterine isthmus to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.

Single tourniquet

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Uterine Tourniquet at Open Myomectomy

Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

Including but not limited to fever, pelvic infections, wound infections.

Surgical blood loss will be estimated by sum of the volume of suction fluid and blood loss quantitated by gravimetric method.

During surgery, if it is possible, irrigation will not be done, surgical sponge and compress will not be used.

* Suction fluid will be measured at the end of operation and volume of irrigation fluid will be subtracted from total suction volume.
* Surgical drapes, sponges and towels will be weighted before and just after surgery. The blood loss will be estimated as differences in gram by weighing when 1ml blood supposed as 1 gr.

Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery	NCT02204930	Hemorrhage	PeproStat	18 Years -	Haemostatix Ltd
AutoTransfusion Versus TRAnsfusion in Cancer Surgery	NCT05452538	Hemorrhage Cancer Surgery Transfusion	Transfusion	18 Years -	Centre Leon Berard
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis	NCT02913365	Hemoptysis Haemoptysis Lung Disease Pneumonia Tuberculosis Bronchiectasis Respiratory Tra... Respiratory Tra... Bronchitis Mycobacterium I... Bronchial Disea... Pulmonary Hemor... Signs and Sympt... Signs and Sympt... Pathologic Proc... Mycosis Hemorrhage Lung Cancer Pulmonary Embol... Arteriovenous F...		18 Years -	Université de Sherbrooke
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery	NCT02204930	Hemorrhage	PeproStat	18 Years -	Haemostatix Ltd
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology	NCT02653261	Hemorrhage	Tranexamic Acid Placebo	18 Years - 90 Years	University Tunis El Manar
Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer	NCT02407717	Hemorrhage Vein Thrombosis		18 Years -	G. d'Annunzio University
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia	NCT03136445	Hematologic Neo... Hemorrhage Hematopoietic S...	Tranexamic acid... Placebo	18 Years -	NHS Blood and Transplant
Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer	NCT02508883	Upper Gastroint...		18 Years -	Instituto do Cancer do Estado de São Paulo
Uterine Tourniquet at Open Myomectomy	NCT02049242	Myomectomy Uterine Leiomyo...	triple tourniqu... Single tourniqu...	16 Years - 48 Years	Ataturk University
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology	NCT02653261	Hemorrhage	Tranexamic Acid Placebo	18 Years - 90 Years	University Tunis El Manar
AutoTransfusion Versus TRAnsfusion in Cancer Surgery	NCT05452538	Hemorrhage Cancer Surgery Transfusion	Transfusion	18 Years -	Centre Leon Berard
Uterine Tourniquet at Open Myomectomy	NCT02049242	Myomectomy Uterine Leiomyo...	triple tourniqu... Single tourniqu...	16 Years - 48 Years	Ataturk University

Spots Global Cancer Trial Database for hemorrhage

Every month we try and update this database with for hemorrhage 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 hemorrhage

Every month we try and update this database with for hemorrhage 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 hemorrhage 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.