Trial Outcomes & Findings for Sickle Cell Trait and the Risk of Venous Thromboembolism (NCT NCT01148940)

Last Updated: 2020-12-17

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

34 participants

Primary outcome timeframe

Date of delivery until 4-5 weeks postpartum.

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	White Women With HbAA White pregnant and post partum women with Hb AA	Black Women With Hb AA Black pregnant and post partum women with HbAA
Overall Study STARTED	7	27
Overall Study COMPLETED	7	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sickle Cell Trait and the Risk of Venous Thromboembolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	White n=7 Participants self-described	Black n=27 Participants self-described	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	27 Participants n=107 Participants	34 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	29.3 years n=99 Participants	29.3 years n=107 Participants	29.3 years n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	27 Participants n=107 Participants	34 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	7 participants n=99 Participants	27 participants n=107 Participants	34 participants n=206 Participants

PRIMARY outcome

Timeframe: Date of delivery until 4-5 weeks postpartum.

Population: did not recruit any women with sickle cell trait

Outcome measures

Outcome measures
Measure	White Women With HbAA n=7 Participants White women pregnant and postpartum with HbAA	Black Women With HbAA n=27 Participants Black women pregnant and postpartum with HbAA	Black Women With SCT Black women pregnant and postpartum with HbAS
D-Dimer Levels Than in Black Women With Hb AA and White Women With Hb AA.	1.370 micrograms/ml Interval 0.773 to 1.853	1.850 micrograms/ml Interval 1.515 to 4.185	—

Adverse Events

White Women With HbAA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Black Women With HbAA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Black Women With SCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Henny Billett

Albert Einstein College of Medicine

Phone: 718-430-2186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place