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NCT01148940 · ClinicalTrials.gov registry record

Sickle Cell Trait and the Risk of Venous Thromboembolism

A clinical trial, sponsored by Albert Einstein College of Medicine.

Terminated
Registry status
34
Enrollment target

NCT01148940: Clinical Trial study, sponsored by Albert Einstein College of Medicine.

NCT01148940 is a clinical trial that was terminated before completion, run by Albert Einstein College of Medicine. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01148940 was terminated before completion, sponsored by Albert Einstein College of Medicine.

TERMINATED
Registry status
34 participants
Enrollment target

Study Summary

The purpose of this trial is to investigate D-Dimer levels, a surrogate marker of venous thromboembolism, in pregnant/postpartum white women as compared to pregnant/postpartum black women, and pregnant/postpartum women with sickle cell trait. The investigators will determine whether increased D-Dimer levels are reflected in a greater incidence of thrombosis in the postpartum patient, as well as the prevalence of symptomatic venous thrombosis in black patients as compared to pregnant white patients and women with sickle cell trait. The investigators will also investigate the effect of blood group on these parameters. If there is evidence that there is an increased risk of thrombosis in sickle cell trait, the investigators will plan a trial of prophylactic anticoagulation during the last trimester and the four weeks post partum for patients with sickle cell trait and compare this population to patients who do not receive prophylactic anticoagulation.

Primary Outcome

High D-Dimer levels are regarded as potentially prothrombotic markers and are often elevated in pregnancy and the postpartum. There are some data to suggest that sickle cell trait may also be prothrombotic.To investigate whether D-Dimer levels are higher in black peripartum women with SCT than in black or white pregnant/postpartum patients who have Hb AA, we will measure the D-Dimer, on a continuous scale, in the pregnant/postpartum population of each group. It is known that D-Dimer levels \>1.0

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2010-07
Est. Completion 2011-06
Albert Einstein College of Medicine

175 total trials

Why NCT01148940 stopped before completion

NCT01148940 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01148940 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01148940 about?

NCT01148940 is a clinical study titled "Sickle Cell Trait and the Risk of Venous Thromboembolism". The purpose of this trial is to investigate D-Dimer levels, a surrogate marker of venous thromboembolism, in pregnant/postpartum white women as compared to pregnant/postpartum black women, and pregnant/postpartum women with sickle cell trait. The investigators will determine whether increased D-Dime...

What is the current status of trial NCT01148940?

This trial is currently terminated. The enrollment target is 34 participants. The study started on 2010-07. Estimated completion is 2011-06.

Who is sponsoring clinical trial NCT01148940?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01148940, the US trial registry maintained by the National Library of Medicine. NCT01148940 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.