SCD Trial Effectively Implements TCD Screening Protocol in Resource-Constrained Settings

A standardized, local transcranial doppler (TCD) supported by central quality review was able to be implemented effectively in resource-constrained settings to screen patients with sickle cell disease (SCD) for high stroke risk, according to a report on the phase III HOPE Kids 2 trial.

Findings will be presented at the 2024 American Society of Pediatric Hematology/Oncology Conference by Robert Brown, MD, PhD, of Emory University in Atlanta, Georgia.

To screen patients for HOPE Kids 2, local sonographers were trained and certified on standard TCD equipment and examination protocols. Screening assessments then underwent central quality review to determine eligibility for randomization.

TCD Screening for Stroke in SCD Implemented

HOPE Kids 2 screened for children with SCD and “conditional” TCD velocity. Normal, conditional, and abnormal velocity were defined via time-average maximum of mean velocity (TAMMV) of <170 cm/s, 170 to <200 cm/s, and ≥200 cm/s, respectively.

From November 2020 to February 2023, a total of 708 participants were evaluated at 29 centers in Nigeria, Kenya, Egypt, Ghana, the United States, Italy, Oman, Saudi Arabia, and the United Kingdom. Of these, 652 (92.1%) completed TCD assessments. The screened cohort had a mean age of 7.6 ± 3.24 years (range, 2.0-14.0), was 50.8% male, and 23.0% were receiving hydroxyurea.

Among screened patients, the mean TAMMV was 163.0 ± 31.26 cm/s and 307 (47.1%) had conditional TAMMV at baseline, while 39 (6.0%) and 306 (46.9%) had abnormal or normal TAMMV at baseline, respectively.

The authors noted elevated TAMMV was more common in children aged two to eight years versus those aged eight to 15 years. Additionally, 66.8% of conditional and 82.1% of abnormal TCD assessments were from patients in the younger age range.

Overall, 236 of 652 screened patients were eligible for randomization in HOPE Kids 2. The mean hemoglobin level was 7.7 ± 1.06 g/dL and TAMMV was 182.7 ± 7.53 cm/s at screening in this cohort.

In their submission, Dr. Brown and colleagues noted that, “for a large interventional trial aimed at reducing the risk of stroke in children with SCD, African and Middle Eastern sites presented relatively few limitations with respect to participant screening.”

Related: How Does SCD Impact Brain Growth in Infants?

Reference

Brown RC, Bello-Manga H, Nduba V, et al. Transcranial doppler screening of children with sickle cell disease in the HOPE Kids 2 trial. Poster #107. Presented at the 2024 American Society of Pediatric Hematology/Oncology Conference; April 3-6, 2024; Seattle, WA.