Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted t… (NCT07250763) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted to the Hospital
United States145 participantsStarted 2023-09-20
Plain-language summary
The goal of this clinical trial study is to test whether a mathematical calculation, using the patient's gender, weight and kidney function, can better predict a patient's heparin goal dose than a flat number of units per patient weight can. Participants will have the first dose of heparin infusion calculated, after which if adjustments are needed, the Hospital's prebuilt table for results driven dosing for this purpose is used. The researchers will compare the time it takes for the participants to get to the desired goal using the patient's information for calculation versus patients in the past who received the medication using the flat rate. The hypothesis is that the patients with enhanced personal data, gender, weight and kidney function, included for the initial dose, will get to their goal lab value sooner and with less chance of delay or overshooting the goal. A quicker time to goal lab value is beneficial to patients in many ways, including earlier treatment of the clot or coronary issue that the patient is experiencing.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years-old
* Diagnosis by the attending physician with one of the following conditions for which anticoagulation with heparin in an Food \& Drug Administration approved indication and considered the standard of care:
* Moderate-intensity anti-Xa protocol: new-onset deep vein thrombosis or pulmonary embolism, or mechanical heart valve
* Low-intensity anti-Xa protocol: atrial fibrillation, acute cardiac syndrome, embolic stroke
* Heparin infusion either has not started or has been initiated in the last 120 minutes
Exclusion Criteria:
* Use of extracorporeal membrane oxygenation or ventricular assist devices such as Impella pumps
* Diagnosis of thrombophilia/hypercoagulable state
* Concurrent use of direct-acting oral anticoagulants or low molecular weight heparins
* Baseline anti-Xa \> 0.7
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients with steady-state anti Xa level within goal range
Timeframe: up to 72 hours from infusion initiation