Sickle Cell Trait and the Risk of Venous Thromboembolism

NCT01148940 | Terminated Results

• 2 other identifiers: 2009-539-0012009-539
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Keywords

sickle cell trait; thrombosis; D-Dimer

Outcome Measures

Primary Outcomes (1)

• D-Dimer Levels Than in Black Women With Hb AA and White Women With Hb AA.

  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.

  Date of delivery until 4-5 weeks postpartum.

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: women who are pregnant or postpartum
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant and postpartum women

You may qualify if:

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

You may not qualify if:

• Hispanic ethnicity

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center (Einstein)

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Thrombosis; Sickle Cell Trait

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Henny Billett
• Organization: Albert Einstein College of Medicine

hbillett@montefiore.org

718-430-2186

Study Officials

• Henny H Billett, MD MSc

  Albert Einstein College of Medicine/Montefiore Medical Ctr

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine and Pathology

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 17, 2020
• Results First Posted: January 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)