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Sickle Cell Trait and the Risk of Venous Thromboembolism (SCT&DVT)

This study has been terminated.
(insufficent enrollment)
Sponsor:
Information provided by (Responsible Party):
Henny Billett, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01148940
First received: June 21, 2010
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition
Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sickle Cell Trait and the Risk of Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • To investigate whether D-Dimer levels differ in black peripartum women with SCT than in black women with Hb AA and white women with Hb AA. [ Time Frame: One year ] [ Designated as safety issue: No ]
    The primary outcome measure will be D-Dimer measured on a continuous scale. We will compare mean D-Dimer of Black SCT women, Black AA women and White AA women using an independent samples t tests if normality assumptions are met and Mann-Whitney test of mean ranks if not. We will use a one-sided, non-inferiority test of


Estimated Enrollment: 200
Study Start Date: July 2010
Study Completion Date: March 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Venous thromboembolism is the major cause of maternal mortality in the United States and there are emerging data that the thrombotic risk is higher in peripartum black women as compared to white women. The reasons are unclear: indeed, the few genetic risk factors for venous thrombosis that have been identified are more common in whites than blacks. This raises the possibility of yet undescribed mutations. To bolster this theory, some intriguing studies have noted a similar frequency of 'familial' thrombosis in blacks and whites, supporting the existence of yet unidentified hereditary component(s). Sickle cell anemia is a genetic disease more prevalent in the black population. Whereas sickle cell anemia has been associated with a prothrombotic state, there are limited data to support a prothrombotic state in sickle cell trait. We plan to examine whether sickle cell trait might play a role in increasing the incidence of thrombosis in the black population.

Peripartum women are 4-5 times more likely to develop venous thrombosis. Scant literature exists on the thrombotic risk in women from different races in the peripartum period and there are no studies evaluating venous thrombosis risk in sickle cell trait women during this time of increased thrombogenicity. In a retrospective analysis of deliveries of 12,000 women at Einstein/Montefiore, a higher incidence of venous thrombosis in black peripartum women was observed and, among the black population, a trend for sickle cell trait women to be at higher risk compared to black women with the normal hemoglobin (Hb) AA.

Given the medical importance and financial/sociological impact of venous thrombosis, it is important to determine whether black women, and specifically black women with sickle cell trait, are really at increased risk for thromboembolic disease during the peripartum period and, if so, what intervention(s) might mitigate this risk. We propose to perform a prospective study investigating peripartum white Hb AA, black Hb AA, and black sickle cell trait women by assessing D-Dimer levels. The D-Dimer levels will be assayed at defined times during the peripartum and correlated with pregnancy complications, as well as neonatal and birth data, thrombosis and, in selected cases, lower extremity duplex ultrasonography. If, after analysis, there is evidence confirming an increased thrombotic risk, we will design and institute an interventional trial. The purpose of this application is to fill in the gaps of current knowledge regarding the role of race in venous thromboembolism, to test different methodologies for studying this significant health problem, and to lay the groundwork for clinical trial development to determine whether therapeutic intervention with prophylactic anticoagulation is beneficial during the peripartum period for patients with sickle cell trait.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant and postpartum women

Criteria

Inclusion Criteria:

  • Peripartum women (White, Black) with Hemoglobin AA or AS

Exclusion Criteria:

  • Hispanic ethnicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148940

Locations
United States, New York
Montefiore Medical Center (Einstein)
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Henny H Billett, MD MSc Albert Einstein College of Medicine/Montefiore Medical Ctr
  More Information

No publications provided

Responsible Party: Henny Billett, Professor of Clinical Medicine and Pathology, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01148940     History of Changes
Other Study ID Numbers: 2009-539-001, 2009-539
Study First Received: June 21, 2010
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
sickle cell trait
thrombosis
D-Dimer

Additional relevant MeSH terms:
Sickle Cell Trait
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Anemia, Sickle Cell
Cardiovascular Diseases
Embolism and Thrombosis
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014