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Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery

NCT00237328 · View on ClinicalTrials.gov ↗

Study Summary

Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibodies to the drug. This immune response can lead to the formation of blood clots, setting the stage for a potential heart attack or stroke. The purpose of this study is to evaluate how often an immune response to heparin leads to the formation of blood clots in individuals who have had heart surgery.

Conditions Studied

Interventions

  • DRUG Heparin

Study Locations (4)

North Carolina

  • University of North Carolina — Chapel Hill
  • Duke University Medical Center — Durham

Minnesota

  • Mayo Clinic, Rochester — Rochester

Wisconsin

  • University of Wisconsin — Madison

Trial Details

FieldValue
Enrollment Target 1,015 participants
Start Date 2006-06
Est. Completion 2012-07

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00237328

The ClinicalTrials.gov registry entry for NCT00237328 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,015 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Thrombosis appearing as the primary indexed condition, and to 1 intervention — of which Heparin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00237328 reports 4 study locations spanning 3 distinct geographic areas — top geographies include North Carolina, Minnesota, Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00237328 about?

NCT00237328 is a clinical study titled "Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery". Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibodies to the drug. This immune response can lead to the formation of blood clots, setting the stage f...

What is the current status of trial NCT00237328?

This trial is currently completed. The enrollment target is 1,015 participants. The study started on 2006-06. Estimated completion is 2012-07.

What conditions does trial NCT00237328 study?

This clinical trial studies the following conditions: Thrombosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00237328?

The interventions under investigation include: Heparin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00237328?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00237328 being conducted?

This trial has 4 study locations across Minnesota, North Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial