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

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ClinicalTrials.gov Identifier: NCT01148940
Recruitment Status : Terminated (insufficent enrollment)
First Posted : June 23, 2010
Results First Posted : January 2, 2020
Last Update Posted : December 17, 2020
Information provided by (Responsible Party):
Henny Billett, Albert Einstein College of Medicine

Brief 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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sickle Cell Trait and the Risk of Venous Thromboembolism
Study Start Date : July 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

White women with Hb AA
White pregnant and postpartum women with Hb AA
Black women with Hb AA
Black pregnant and postpartum women with HbAA
Black women with Sickle Trait
Black pregnant and postpartum women with HbAS

Primary Outcome Measures :
  1. D-Dimer Levels Than in Black Women With Hb AA and White Women With Hb AA. [ Time Frame: Date of delivery until 4-5 weeks postpartum. ]
    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 mg/ml may be predictive of increased thrombotic risk. We will compare mean D-Dimer of Black SCT women, Black AA women and White AA women to determine whether higher D-Dimer levels, which may be a measure of hypercoagulability, are higher in women with SCT.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women who are pregnant or postpartum
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant and postpartum women

Inclusion Criteria:

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

Exclusion Criteria:

  • Hispanic ethnicity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148940

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United States, New York
Montefiore Medical Center (Einstein)
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
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Principal Investigator: Henny H Billett, MD MSc Albert Einstein College of Medicine/Montefiore Medical Ctr
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Responsible Party: Henny Billett, Professor of Clinical Medicine and Pathology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01148940    
Other Study ID Numbers: 2009-539-001
2009-539 ( Other Identifier: IRB No. )
First Posted: June 23, 2010    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans at present
Keywords provided by Henny Billett, Albert Einstein College of Medicine:
sickle cell trait
Additional relevant MeSH terms:
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Venous Thromboembolism
Sickle Cell Trait
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn