CLINICAL TRIAL

Warfarin for Hemorrhage

Recruiting · 18+ · All Sexes · Montreal, Canada

This study is evaluating whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke.

See full description

About the trial for Hemorrhage

Eligible Conditions
Bleeding Post-mechanical Valve Replacement · Thromboembolism · Hemorrhage · Thromboembolism Post-mechanical Valve Replacement

Treatment Groups

This trial involves 2 different treatments. Warfarin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Warfarin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Warfarin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Warfarin
FDA approved

Side Effect Profile for Edoxaban

Edoxaban
Show all side effects
5%
Atrial fibrillation
0%
Sick sinus syndrome
0%
Endocarditis bacterial
0%
Death
0%
Thrombophlebitis
0%
Aortic aneurysm rupture
0%
Traumatic haemorrhage
0%
Drug effect increased
0%
Atrial flutter
0%
Oxygen saturation decreased
0%
Cardiac arrest
0%
Atrioventricular block complete
0%
International normalised ratio fluctuation
0%
Cardiac failure congestive
0%
Cardiac failure acute
0%
Myocardial infarction
0%
Torsade de pointes
0%
Chordae tendinae rupture
0%
Ventricular tachycardia
0%
Hypokalaemia
0%
Hypocoagulable state
0%
Acute pulmonary oedema
0%
Pulomonary haemorrhage
0%
Anaemia
0%
Spigelian hernia
0%
Diarrhea
0%
Iron deficiency anaemia
0%
Osteoarthritis
0%
Presyncope
0%
Eczema
0%
Sepsis
0%
Clostridium difficile infection
0%
Cellulitis
0%
Rhabdomyolysis
0%
Hyponatraemia
0%
Chronic sinusitis
0%
Pneumonia haemophilus
0%
Urosepsis
0%
Injection site bruising
0%
Liver function test abnormal
0%
Atrioventricular block second degree
0%
Sinus bradycardia
0%
Haematuria
0%
Cystitis haemorrhagic
0%
Acute respiratory distress syndrome
0%
Syncope
0%
Transient ischaemic attack
0%
Headache
0%
Haemorrhoidal haemorrhage
0%
Infective aneurysm
0%
Lung infection
0%
Liver abscess
0%
Loss of consciousness
0%
Deep vein thrombosis
0%
Hypertensive crisis
0%
Haemodynamic instability
0%
Peripheral artery thrombosis
0%
Peripheral embolism
0%
Asthenia
0%
Basal cell carcinoma
0%
Post procedural haemorrhage
0%
Non-small cell lung cancer
0%
Alcohol poisoning
0%
Concussion
0%
Haematochezia
0%
Angina pectoris
0%
Arrhythmia
0%
Cardio-respiratory arrest
0%
Coronary artery stenosis
0%
Chronic obstructive pulmonary disease
0%
Retroperitoneal haemorrhage
0%
Lower gastrointestinal haemorrhage
0%
Renal failure acute
0%
Haemarthrosis
0%
Pneumonia
0%
Erysipelas
0%
Hyperadrenocorticism
0%
Dehydration
0%
Retroperitoneal haematoma
0%
Back pain
0%
Cardiac failure
0%
Mitral valve incompetence
0%
Tachycardia
0%
Bronchiectasis
0%
Bradycardia
0%
Epistaxis
0%
Respiratory failure
0%
Coagulation test abnormal
0%
Blood urine present
0%
Acute myocardial infarction
0%
Angina unstable
0%
International normalised ratio increased
0%
Left ventricular failure
0%
Lower respiratory tract infection
0%
Arthritis bacterial
0%
Mediastinal cyst
0%
Palpitations
0%
Pulmonary oedema
0%
Ankle fracture
0%
Gastroenteritis
0%
Oesophageal carcinoma
0%
Vertigo positional
0%
Pancreatitis
0%
Leukocytosis
0%
Cerebrovascular accident
Atrial fibrillation
5%
Sick sinus syndrome
0%
Endocarditis bacterial
0%
Death
0%
Thrombophlebitis
0%
Aortic aneurysm rupture
0%
Traumatic haemorrhage
0%
Drug effect increased
0%
Atrial flutter
0%
Oxygen saturation decreased
0%
Cardiac arrest
0%
Atrioventricular block complete
0%
International normalised ratio fluctuation
0%
Cardiac failure congestive
0%
Cardiac failure acute
0%
Myocardial infarction
0%
Torsade de pointes
0%
Chordae tendinae rupture
0%
Ventricular tachycardia
0%
Hypokalaemia
0%
Hypocoagulable state
0%
Acute pulmonary oedema
0%
Pulomonary haemorrhage
0%
Anaemia
0%
Spigelian hernia
0%
Diarrhea
0%
Iron deficiency anaemia
0%
Osteoarthritis
0%
Presyncope
0%
Eczema
0%
Sepsis
0%
Clostridium difficile infection
0%
Cellulitis
0%
Rhabdomyolysis
0%
Hyponatraemia
0%
Chronic sinusitis
0%
Pneumonia haemophilus
0%
Urosepsis
0%
Injection site bruising
0%
Liver function test abnormal
0%
Atrioventricular block second degree
0%
Sinus bradycardia
0%
Haematuria
0%
Cystitis haemorrhagic
0%
Acute respiratory distress syndrome
0%
Syncope
0%
Transient ischaemic attack
0%
Headache
0%
Haemorrhoidal haemorrhage
0%
Infective aneurysm
0%
Lung infection
0%
Liver abscess
0%
Loss of consciousness
0%
Deep vein thrombosis
0%
Hypertensive crisis
0%
Haemodynamic instability
0%
Peripheral artery thrombosis
0%
Peripheral embolism
0%
Asthenia
0%
Basal cell carcinoma
0%
Post procedural haemorrhage
0%
Non-small cell lung cancer
0%
Alcohol poisoning
0%
Concussion
0%
Haematochezia
0%
Angina pectoris
0%
Arrhythmia
0%
Cardio-respiratory arrest
0%
Coronary artery stenosis
0%
Chronic obstructive pulmonary disease
0%
Retroperitoneal haemorrhage
0%
Lower gastrointestinal haemorrhage
0%
Renal failure acute
0%
Haemarthrosis
0%
Pneumonia
0%
Erysipelas
0%
Hyperadrenocorticism
0%
Dehydration
0%
Retroperitoneal haematoma
0%
Back pain
0%
Cardiac failure
0%
Mitral valve incompetence
0%
Tachycardia
0%
Bronchiectasis
0%
Bradycardia
0%
Epistaxis
0%
Respiratory failure
0%
Coagulation test abnormal
0%
Blood urine present
0%
Acute myocardial infarction
0%
Angina unstable
0%
International normalised ratio increased
0%
Left ventricular failure
0%
Lower respiratory tract infection
0%
Arthritis bacterial
0%
Mediastinal cyst
0%
Palpitations
0%
Pulmonary oedema
0%
Ankle fracture
0%
Gastroenteritis
0%
Oesophageal carcinoma
0%
Vertigo positional
0%
Pancreatitis
0%
Leukocytosis
0%
Cerebrovascular accident
0%
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02072434) in the Edoxaban ARM group. Side effects include: Atrial fibrillation with 5%, Sick sinus syndrome with 0%, Endocarditis bacterial with 0%, Death with 0%, Thrombophlebitis with 0%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I have had a bileaflet mechanical heart valve implanted in my aorta three or more months ago. show original
must be obtained in any setting where an invasive or non-invasive procedure is to be performed show original
You must be 18 years or older when you enrol in the program. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: One year
Screening: ~3 weeks
Treatment: Varies
Reporting: One year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: One year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Warfarin will improve 1 primary outcome and 6 secondary outcomes in patients with Hemorrhage. Measurement will happen over the course of One year.

Crossover of INR target arms
ONE YEAR
Percent of patients that crossover INR target arms
ONE YEAR
Recruitment rate
ONE YEAR
Recruitment of 200 subjects at 5 centres over 1 year
ONE YEAR
New valve patients consented/approached
ONE YEAR
Percent of new valve (<1 year) patients consented/approached
ONE YEAR
Patients at low risk vs. high risk (as per the PROACT definition)
1 YEAR
Percent of participants at low vs. high risk (as per the PROACT definition: those without 1 of the following conditions were considered in the low-risk group: chronic atrial fibrillation, left ventricular ejection fraction <30%, left atrial dimension >50 mm, spontaneous echocardiographic contrast in the left atrium, significant vascular disease, history of neurological events within 1 year, hypercoagulability, left or right ventricular aneurysm, and women receiving estrogen replacement therapy)
1 YEAR
Patients prescribed concomitant anti-platelet agent
ONE YEAR
Percent of patients prescribed concomitant anti-platelet agent
ONE YEAR
Valve patients consented/approached
ONE YEAR
Percent of established prevalent (>1 year) valve patients consented/approached
ONE YEAR
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Who is running the study

Principal Investigator
E. B.
Emilie Belley-Cote, Principal Investigator
Population Health Research Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can hemorrhage be cured?

The possibility of cure and remission of non-therapeutic hemorrhage may not be unrealistically high if the hemorrhage is in a location with good access to hemostatic treatment. For other hemorsias, there may be a lesser prospect for cure and remission. At a glance, such a scenario may seem plausible.

Anonymous Patient Answer

What is hemorrhage?

Data from a recent study shows that in our setting, a common occurrence observed in the community, hemorrhage is most often related to vascular or cardiac pathology. Patients who present to the emergency departments with anemia and hematuria may have life-threatening conditions that need immediate attention. It is possible that hematuria could be caused by trauma or intra-abdominal hemorrhage. If one does not have definitive clues of a vascular or cardiovascular source for a patient with an abnormal medical history and physical examination, then a thorough search for hematuria is necessary. Hemorrhage from trauma is rarely life-threatening, but hematuria is not always benign.

Anonymous Patient Answer

What causes hemorrhage?

Causes include infections, trauma, and tumors. Hemorrhaging from a ruptured aneurysm can produce a sudden, life-threatening drop in blood pressure, and treatment for a ruptured abdominal aneurysm should be urgent.

Anonymous Patient Answer

What are the signs of hemorrhage?

Signs and symptoms of hemorrhage involve excessive bleeding, excessive bruising, bleeding from the nose or gums, and vomiting blood. Symptoms typically occur suddenly, but may begin slowly. Symptoms may also be mistaken for anemia, which is the cause of many signs of hemorrhage.\n

Anonymous Patient Answer

What are common treatments for hemorrhage?

Most hematomas are safely managed nonsurgically and conservatively with basic first aid techniques. If nonsurgically, oxygen can alleviate the pain. Surgery is often needed in those with life-threatening injuries. In addition to first aid, intravenous fluids may be indicated. For those with unstable pulse or severe bleeding, prompt surgery is the mainstay of management. Most patients have no long-term complications.

Anonymous Patient Answer

How many people get hemorrhage a year in the United States?

In the US at least 20,000 people die a year from hemorrhage from any cause; roughly 60% can be prevented through a combination of health check-ups, immunization, and blood pressure control.

Anonymous Patient Answer

How serious can hemorrhage be?

Hemorrhagic shock, shock from intracerebral hemorrhage, hematuria, shock and blood clotting disorders, shock, shock from cardiac tamponade or aortic dissection, and severe shock are high-risk factors that increase the risk of death in trauma patients. Blood transfusions and cardiopulmonary bypass do not seem to be associated with worsening outcomes. The high incidence of death from shock in trauma patients with blood loss greater than 3,000ml is concerning, and a new definition of massive hemorrhagic shock is needed to identify victims of traumatic death more accurately.

Anonymous Patient Answer

What does warfarin usually treat?

Warfarin may reduce the number of acute cardiac procedures performed in patients with noncoagulation disorders and in those with concomitant ischemic cardiomyopathy and/or pulmonary embolism.

Anonymous Patient Answer

Who should consider clinical trials for hemorrhage?

[The need for early intervention and high-quality care to achieve high rates of survival is indisputable] and the potential for medical breakthrough can only be optimally addressed by clinical trials; this implies that clinical trials could be performed by experts who would be trained in the specific design of studies that may have high levels of relevance.

Anonymous Patient Answer

What is the average age someone gets hemorrhage?

[Approximately 18.2 years old as a mean age] was found to be very similar to the U.S. average age of 18.8 years according to the U.S. Census.\n

Anonymous Patient Answer

What is warfarin?

warfarin is commonly used, but knowledge of its appropriate use is variable. Warfarin was once widely used for deep venous thrombosis and stroke with potentially devastating consequences ("warfarin syndrome"). Current recommendations for its use are carefully managed in accordance with the American College of Chest Physicians practice guidelines. This is a challenging task for a general practitioner since, the vast majority of patients need anticoagulation and, the drugs available to them are limited, while the available evidence to the contrary is inconsistent ("no difference"; "some difference"; "difference of no significance").

Anonymous Patient Answer

What are the common side effects of warfarin?

The most common side effects of warfarin were haemorrhage and bruising. Because of the risks and disadvantages of warfarin use, the need to adjust the anticoagulation regimen should be addressed. The most common side effect of anti-thrombotic agents should also be noted and followed up with closely.

Anonymous Patient Answer
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