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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Thrombosis
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title White Women With HbAA Black Women With Hb AA Black Women With SCT
Hide Arm/Group Description White pregnant and post partum women with Hb AA Black pregnant and post partum women with HbAA Black pregnant and postpartum women with HbAS
Period Title: Overall Study
Started 7 27 0
Completed 7 27 0
Not Completed 0 0 0
Arm/Group Title White Black Total
Hide Arm/Group Description self-described self-described Total of all reporting groups
Overall Number of Baseline Participants 7 27 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 27 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
27
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 7 participants 27 participants 34 participants
29.3
(18.2 to 39.1)
29.3
(18.2 to 39.1)
29.3
(18.2 to 39.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 27 participants 34 participants
Female
7
 100.0%
27
 100.0%
34
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 27 participants 34 participants
7 27 34
1.Primary Outcome
Title D-Dimer Levels Than in Black Women With Hb AA and White Women With Hb AA.
Hide Description 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.
Time Frame Date of delivery until 4-5 weeks postpartum.
Hide Outcome Measure Data
Hide Analysis Population Description
did not recruit any women with sickle cell trait
Arm/Group Title White Women With HbAA Black Women With HbAA Black Women With SCT
Hide Arm/Group Description:
White women pregnant and postpartum with HbAA
Black women pregnant and postpartum with HbAA
Black women pregnant and postpartum with HbAS
Overall Number of Participants Analyzed 7 27 0
Mean (95% Confidence Interval)
Unit of Measure: micrograms/ml
1.370
(.773 to 1.853)
1.850
(1.515 to 4.185)
Time Frame Blood was collected on day 7-10 post delivery and again at 4 weeks post partum. Total duration was therefore about 4-5 weeks. Study duration was July 2010 - June 2011
Adverse Event Reporting Description The only potential adverse events were the 1) potential for the inadvertent release of protected health information and 2) the risks of venipuncture including local ecchymoses and rarely, syncope. Neither of these adverse events occurred. The only group were there were 0 potentially at risk was the SCT group - that is because no SCT patients were in the study.
 
Arm/Group Title White Women With HbAA Black Women With HbAA Black Women With SCT
Hide Arm/Group Description White pregnant/postpartum women with HbAA black pregnant/postpartum women with HbAA black women with HbAS
All-Cause Mortality
White Women With HbAA Black Women With HbAA Black Women With SCT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/27 (0.00%)   0/0 
Hide Serious Adverse Events
White Women With HbAA Black Women With HbAA Black Women With SCT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/27 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
White Women With HbAA Black Women With HbAA Black Women With SCT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/27 (0.00%)   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Henny Billett
Organization: Albert Einstein College of Medicine
Phone: 718-430-2186
EMail: hbillett@montefiore.org
Layout table for additonal information
Responsible Party: Henny Billett, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01148940    
Other Study ID Numbers: 2009-539-001
2009-539 ( Other Identifier: IRB No. )
First Submitted: June 21, 2010
First Posted: June 23, 2010
Results First Submitted: October 16, 2019
Results First Posted: January 2, 2020
Last Update Posted: December 17, 2020