Trial Outcomes & Findings for Glucose Regulation in Acute Stroke Patients (GRASP) Study (NCT NCT00282867)

NCT ID: NCT00282867

Last Updated: 2009-08-21

Results Overview

hypoglycemic events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: up to 5 days
• Results posted on: 2009-08-21

Participant Flow

Participant milestones

Measure	Tight Control Group target glucose level 70-110 mg/dL	Loose Control Group target glucose level 70 - 200 mg/dL	Usual Care Group target level 70 - 300 mg/dL
Overall Study STARTED	24	25	25
Overall Study COMPLETED	23	24	25
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	Tight Control Group target glucose level 70-110 mg/dL	Loose Control Group target glucose level 70 - 200 mg/dL	Usual Care Group target level 70 - 300 mg/dL
Overall Study d/c prior to prim outcome, 3 m f/u done	1	1	0

Baseline Characteristics

Glucose Regulation in Acute Stroke Patients (GRASP) Study

Baseline characteristics by cohort

Measure	Tight Control Group n=24 Participants target glucose level 70-110 mg/dL	Loose Control Group n=25 Participants target glucose level 70 - 200 mg/dL	Usual Care Group n=25 Participants target level 70 - 300 mg/dL	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	25 participants n=5 Participants	74 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 5 days

hypoglycemic events

Outcome measures

Measure	Tight Control Group n=23 Participants target glucose level 70-110 mg/dL	Loose Control Group n=24 Participants target glucose level 70 - 200 mg/dL	Usual Care Group n=25 Participants target level 70 - 300 mg/dL
Hypoglycemic Events	7 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 3 months

3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.

Outcome measures

Measure	Tight Control Group n=23 Participants target glucose level 70-110 mg/dL	Loose Control Group n=24 Participants target glucose level 70 - 200 mg/dL	Usual Care Group n=25 Participants target level 70 - 300 mg/dL
Favorable 3 Month Modified Rankin	42 percentage of participants	25 percentage of participants	33 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 5 days

symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period

Outcome measures

Measure	Tight Control Group n=23 Participants target glucose level 70-110 mg/dL	Loose Control Group n=24 Participants target glucose level 70 - 200 mg/dL	Usual Care Group n=25 Participants target level 70 - 300 mg/dL
Symptomatic Hypoglycemia	0 participants	1 participants	0 participants

POST_HOC outcome

Timeframe: first 24 hours after initiation of treatment

Population: Per protocol no analysis of this endpoint was performed in the "usual care" group.

glucose in target range in first 24 hours

Outcome measures

Measure	Tight Control Group n=23 Participants target glucose level 70-110 mg/dL	Loose Control Group n=24 Participants target glucose level 70 - 200 mg/dL	Usual Care Group target level 70 - 300 mg/dL
Target Glucose Concentration	10 participants	22 participants	—

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen C. Johnston, MD, MSc

University of Virginia

Phone: 434 924-5323

Email: kj4v@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place