Testing standardized perioperative for thrombosis
Official title: Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)
Active Cancer Patients Having Cancer Related Invasive Procedures or Surgery and Needing Perioperative Management of Anticoagulation Therapy (ACE-HIGH): A Prospective Management Cohort Study
- 1 group
- One site, in Ottawa
- Recruiting
Interventions
- Other intervention
standardized perioperative anticoagulation management Guideline
The intervention is implementing a standardized perioperative anticoagulation management strategy in patients with active cancer (and this strategy is consistent with guideline-directed care for patients with active cancer).
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years
- +Prescribed a Direct Oral Anticoagulant (DOAC), warfarin (International Normalized Ratio (INR) target 2.0-3.0) or Low Molecular Weight Heparin (LMWH) (75-100% weight-based therapeutic dosing) for stroke prevention in Atrial Fibrillation (AF) or the treatment of Venous Thromboembolism (VTE). Eligible DOAC regimens include full-dose (therapeutic) DOAC regimens appropriate for age and renal function. Eligible DOAC regimens include:
- +i. Apixaban 10 mg po BID (VTE) ii. Apixaban 5 mg po BID (AF or VTE) iii. Apixaban 2.5 mg po BID (AF) iv. Rivaroxaban 15 mg po BID (VTE) v. Rivaroxaban 20 mg po OD (AF or VTE) vi. Rivaroxaban 15 mg po OD (AF only) vii. Edoxaban 60 mg po OD (AF or VTE) viii. Edoxaban 30 mg po OD (AF or VTE) ix. Dabigatran 150 mg po BID (AF or VTE) x. Dabigatran 110 mg po BID (AF)
- +Has active cancer, defined as:
- +i. cancer diagnosed within 6 months ii. recurrent, regionally advanced, or metastatic cancer iii. cancer for which treatment had been administered within 6 months before enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → iv. hematologic cancer that is not in remission v. Patients who are felt to likely have active cancer based on clinical/imaging characteristics but are awaiting tissue confirmation and are scheduled for a biopsy procedure are eligible for trial inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →
- +Interruption of anticoagulation therapy for the planned procedure is required.
- +Is undergoing a planned cancer-related inpatient or outpatient invasive procedure or cancer surgery (to diagnose, treat or palliate cancer; at investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s discretion)
Exclusion
- −Allergy to heparin or a history of (Heparin Induced Thrombocytopenia (HIT)
- −Presence of any mechanical prosthetic heart valve
- −Severe renal insufficiency (Creatinine Clearance (CrCl) \< 30 mL/min or \< 25 mL/min for Apixaban users)
- −Condition that might impair adherence to the study protocolProtocolThe detailed plan a study must follow.Read more → (e.g., cognitive impairment, geographic inaccessibility) as determined by the treating physician
- −Previous study participation
- −Inability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Known pregnancy or breastfeeding
- −More than one surgery/procedure planned during the study period
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives standardized perioperative anticoagulation management Guideline.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 700 people.
The study is currently expected to finish around December 2031.
The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of study follow ups at 4 weeks".
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Major bleeding events — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of study follow ups at 4 weeks".
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07372716 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About standardized perioperative anticoagulation management GuidelineOther
The intervention is implementing a standardized perioperative anticoagulation management strategy in patients with active cancer (and this strategy is consistent with guideline-directed care for patients with active cancer).
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of study follow ups at 4 weeks".
The study as a whole is currently expected to finish around 2031-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 700 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Ottawa, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to help find how safe current practices are when managing blood thinners in people with cancer who are having surgery or medical procedures. Investigators will also measure how often bleeding or clotting problems happen in this setting. The goal is to use this information to improve future care and reduce these risks for patients. This study will determine whether contemporary practices can be safely applied to cancer patients, and also evaluate the blood thinner level left over in patient's body at the time of surgery.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.