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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
Sponsor:
Information provided by (Responsible Party):
Henny Billett, Albert Einstein College of Medicine

Tracking Information
First Submitted Date June 21, 2010
First Posted Date June 23, 2010
Results First Submitted Date October 16, 2019
Results First Posted Date January 2, 2020
Last Update Posted Date December 17, 2020
Study Start Date July 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2019)
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.
Original Primary Outcome Measures
 (submitted: June 22, 2010)
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 ]
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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 22, 2010)
Thromboprophylaxis for peripartum SCT [ Time Frame: 3 years ]
If there is evidence of an increased risk of thrombosis, we will investigate whether therapeutic intervention is beneficial by planning a trial of prophylactic anticoagulation during the peripartum period for women with SCT.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sickle Cell Trait and the Risk of Venous Thromboembolism
Official Title Sickle Cell Trait and the Risk of Venous Thromboembolism
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pregnant and postpartum women
Condition Thrombosis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: December 16, 2019)
34
Original Estimated Enrollment
 (submitted: June 22, 2010)
500
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hispanic ethnicity
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: women who are pregnant or postpartum
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01148940
Other Study ID Numbers 2009-539-001
2009-539 ( Other Identifier: IRB No. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No plans at present
Responsible Party Henny Billett, Albert Einstein College of Medicine
Study Sponsor Albert Einstein College of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Henny H Billett, MD MSc Albert Einstein College of Medicine/Montefiore Medical Ctr
PRS Account Albert Einstein College of Medicine
Verification Date December 2020