Monitoring Methods for Blood Clots

N/A

Waitlist Available

Led By Benjamin Tillman, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation.

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods, activated partial thromboplastin time (PTT) and chromogenic anti-factor Xa assay (anti-Xa), for monitoring unfractionated heparin (UF

Who is the study for?

This trial is for hospitalized patients who need intravenous anticoagulation with unfractionated heparin to treat or prevent blood clots. Specific eligibility criteria are not provided, but typically participants would be adults without conditions that could interfere with the study.

What is being tested?

The trial compares two methods of monitoring the effectiveness of heparin: the PTT protocol and the anti-Xa protocol. It aims to find out which method helps patients reach the desired level of blood thinning more quickly.

What are the potential side effects?

While specific side effects are not listed, common ones associated with heparin include bleeding, bruising at injection sites, low platelet count (heparin-induced thrombocytopenia), and osteoporosis with long-term use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to therapeutic anticoagulation range

Secondary study objectives

Coagulation laboratory measurements

Measurements in therapeutic anticoagulation range

New clinically relevant bleeding events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Active Comparator: anti-Xa protocolActive Control1 Intervention

Patients randomized to this arm will be monitored using the pharmacy-managed anti-Xa protocol. This includes patients on both high- and low-dose heparin protocols.

Group II: Active Comparator: PTT protocolActive Control1 Intervention

Patients randomized to this arm will be monitored using the nurse-managed PTT guided protocol. This includes patients on both high- and low-dose heparin protocols.

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