Back to search results

Gruticibart to Prevent Catheter-Related Blood Clots

This study is looking at whether a single dose of gruticibart can prevent blood clots (thrombosis) that can form around a central venous catheter (CVC). Many patients with CVCs develop these clots, which can cause pain and swelling, and often require blood thinners that increase bleeding risk. Gruticibart is a type of monoclonal antibody, which is a specific kind of drug that may help prevent these clots. We want to see how safe and effective gruticibart is in reducing the number of these clots and how often serious bleeding occurs. You might be able to join if you are 18 or older and your treatment plan allows for a 1-2 day period between receiving the study drug and starting your next planned therapy. The study aims to enroll 90 participants.

Study design
This is an interventional study where participants are randomly assigned to receive either gruticibart or a placebo. The study plans to enroll 90 participants.
What's involved
You would receive a single dose of either gruticibart or placebo through an IV or catheter. You would also have ultrasounds of your CVC and legs, and blood samples collected.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects for 30 days after receiving the study drug, and for catheter-related thrombosis and bleeding up to 14 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07498517

Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
OHSU Knight Cancer Institute
~90 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:PlaceboGruticibartUltrasoundBiopspecimen collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with catheter-related thrombosis
Measured over Day 1 to end of follow up (up to 14 days)
+1 more outcome measured

Conditions

Thrombosis

Explore related trials

Thrombosis

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Joseph Shatzel, M.D. · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Joseph Shatzel, M.D.
[email protected]
503-494-6594
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Ability to understand and the willingness to sign a written informed consent document.
Men and women, aged ≥ 18 years.
In consultation with PI and treating physician, participant's therapy allows for a 1 to 2-day period between administration of study drug and subsequent start of planned therapy.
Individuals that will undergo insertion of a CVC as part of planned therapy per institutional standards.
Must have ECOG performance status ≤ 2 (refer to Appendix A).
At time of enrollment, must have:
Platelet count \> 50 x 109/L
Female participants of childbearing potential must have a negative urine or serum pregnancy test during screening and at check-in Day -1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
Female participants of childbearing potential must agree to use two forms of highly effective contraception (Appendix B) starting with the first dose of study therapy through 90 days after the last dose of study therapy.
Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.

Exclusion

Concurrent enrollment in another therapeutic clinical trial
Active leukemia (lymphoma and myeloma may be included)
Primary brain tumors or known brain metastases
Active infection and/or current use of an oral antibiotic
At time of enrollment:
Deranged baseline clotting, where INR \> 1.5
Known bleeding diathesis
Use of anticoagulation, either therapeutic or prophylactic, for any indication at enrollment
-At the discretion of the investigator, any other contraindication to anticoagulation therapy
Previously documented hypersensitivity to either the drug or excipients.
Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements.
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after study drug administration.

What this trial measures

  • Number of participants with catheter-related thrombosisDay 1 to end of follow up (up to 14 days)

    Defined by the total incidence of symptomatic and asymptomatic thrombosis.

  • Incidence of major and clinically-relevant bleedingDay 1 up to end of treatment (up to 14 days)

    Safety outcome is defined using the International Society of Thrombosis and Hemostasis definition of major bleeding for clinical investigations of anti-hemostatic medicinal products in nonsurgical patients