Stroke prevention in nigeria: spring 2

Active Cooperative Agreement Awarded Last action

Award ID
U01NS129143
Recipient
Awarding agency
Obligated
$3,190,424

Award facts

Completion date 53% complete
Originally
Place of performance
Nashville, TN 37203, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
We propose a multicenter open-label, single-arm type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in children with sickle cell anemia (SCA) living in nigeria. Our team just completed a double-blind, parallel-group phase III randomized controlled trial (SPRING), where we compared low-dose to moderate-dose hydroxyurea for primary stroke prevention in children with SCA and abnormal transcranial doppler (TCD) velocities (>200 CM/SEC). Children with abnormal TCD velocities have a high stroke risk of approximately 10.7 events per 100 person-years (observation arm in the stop trial). In the low- (N=109) and moderate-dose (N=111) hydroxyurea groups, the stroke incidence rates were 1.2 and 1.9 per 100 person- years, respectively, P=0.77 (combined incidence rate 1.5 per 100 person-year). Despite equal efficacy for stroke prevention in both treatment groups, moderate- when compared to low-dose hydroxyurea, was more effective in preventing severe acute pain and all-cause hospitalizations. Our findings supported the american society of hematology's evidence-based guidelines for hydroxyurea therapy for primary stroke prevention in low-income settings. Our hypothesis to be tested: in a multicenter single-arm type I hybrid trial, for children with abnormal TCD velocities treated with hydroxyurea, the stroke incidence rate will be non-inferior to the SPRING trial results, with an upper non-inferiority margin of 4 strokes per 100-person-years. The point estimate method was used to determine the non-inferiority margin based on the nigerian pediatrician's judgment of what maximum stroke rate would be clinically meaningful to demonstrate the effectiveness and justify treatment for the high-risk stroke group. A non-inferiority test with an overall sample size of 220 participants will achieve 91% power at a 0.050 significance level to detect non-inferiority when the expected proportion of strokes is 0.035, a minimum follow-up period of 2.5 years and a loss to follow-up of 10% per year. Participants will be followed as per standard care, including clinic visits every 3 months and complete blood cell counts every 6 months. We will conduct the following aims:1) determine the incidence of the first stroke and TIA in children with abnormal TCD velocities treated with hydroxyurea for 2.5 years in the type 1 hybrid trial; 2) evaluate the implementation and sustainability of the intervention within the extended RE-aim framework; 3) evaluate the cost-effectiveness of low- compared to a higher dose of hydroxyurea for primary stroke prevention in children with abnormal TCD velocities. Capacity building for the three nigerian multiple principal investigators, the statisticians, and nurses will be focused on three areas- a) developing a nigerian data coordinating center and the required skills to support a clinical trial; B) developing a regional TCD course for nurses, enhancing task shifting and reach, and C) performing cost-effective analysis for the type I hybrid trial comparing low-and moderate dose hydroxyurea.

Transactions

Action Obligated Date
Amendment $369,257
Amendment $10,000
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Amendment $116,949
Amendment $116,949
Amendment $116,949
Amendment $0
Amendment $0
Amendment $10,000
Amendment $10,000
Amendment $10,000
Amendment $607,580
Amendment $607,580
Amendment $607,580
Original award $607,580
Show all 19

Subawards

Subrecipient Amount Awarded
Aminu Kano Teaching Hospital Stroke Prevention in Nigeria: SPRING 2 $369,257
The Washington University $21,758
The Ohio State University $38,005
Aminu Kano Teaching Hospital $47,982
Subrecipient not on record $50,000
Subrecipient not on record $229,672
The Washington University $21,062
The Ohio State University $20,075
The Washington University $25,353
Subrecipient not on record $192,316
The Ohio State University $22,916
Show all 11

Quick answers

Who received award U01NS129143?

U01NS129143 was awarded to Vanderbilt University Medical Center by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on September 1, 2023.

How much is award U01NS129143 worth?

$3,190,424 has been obligated on U01NS129143.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award
Try for free Login