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NCT01811550 · ClinicalTrials.gov registry record
Study of Procoagulation Markers in Stroke Patients
A clinical trial, sponsored by Temple University.
- Completed
- Registry status
- 271
- Enrollment target
NCT01811550: Completed study, sponsored by Temple University.
NCT01811550 is a clinical trial that has completed, run by Temple University. The registered enrollment target is 271 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01811550 has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- 271 participants
- Enrollment target
Study Summary
The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT): Response to Insulin Administration and Blood Glucose Control proposal is designed to accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III multicenter, randomized, controlled trial planning to determine the efficacy and validate the safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of hyperglycemia control with intravenous (IV) insulin therapy or control therapy with subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood coagulation marker levels will be measured before and at 48 hours after the start of treatment. Baseline and temporal changes in biomarkers levels will be compared between treatment groups. Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the standard fashion. Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity adjusted measure of functional ability at 90 days after AIS). Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ Insulin-treated with or without favorable outcomes at 90 days after AIS.
Interventions
- OTHER Glycemic Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2012-08 |
| Est. Completion | 2019-01 |
What the finished NCT01811550 record still lists
NCT01811550 is an observational study that tracks outcomes without assigning an intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Glycemic Control is the first listed.
NCT01811550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01811550 about?
NCT01811550 is a clinical study titled "Study of Procoagulation Markers in Stroke Patients". The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT): Response to Insulin Administration and Blood Glucose Control proposal is designed to accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III multicenter, randomized, controlle...
What is the current status of trial NCT01811550?
This trial is currently completed. The enrollment target is 271 participants. The study started on 2012-08. Estimated completion is 2019-01.
What interventions are being tested in trial NCT01811550?
The interventions under investigation include: Glycemic Control (OTHER).
Who is sponsoring clinical trial NCT01811550?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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