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Vitamin

Thiamine 500 mg IV for Cardiac Arrest (THACA Trial)

Phase 2
Waitlist Available
Led By Michael W Donnino, MD
Research Sponsored by Michael Donnino
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be assessed up to 30 and 90 days
Awards & highlights

THACA Trial Summary

This trial will test whether giving thiamine (vitamin B1) intravenously to people who have had a cardiac arrest will improve oxygen use by cells and reduce biomarkers of brain injury.

Eligible Conditions
  • Cardiac Arrest

THACA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be assessed up to 30 and 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be assessed up to 30 and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Acute Renal Failure
Biomarkers of Neurologic Injury
Cellular Oxygen Consumption
+9 more

Side effects data

From 2010 Phase 3 trial • 104 Patients • NCT01263132
34%
Drowsiness
32%
Dizziness
8%
Headache
5%
Hypoglycemia
3%
Colitis
3%
Lower Limb Edema
3%
Viral Rhinopharyngitis
3%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
MF0434 + Gabapentin

THACA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ThiamineExperimental Treatment1 Intervention
Patients randomized to the thiamine arm will receive thiamine 500mg in 100mL of normal saline intravenously every 12 hours for 5 doses. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.
Group II: PlaceboPlacebo Group1 Intervention
Patients randomized to placebo will receive 100mL normal saline intravenously every 12 hours for 5 doses. All other aspects of the protocol will be the same as in the experimental arm. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.

Find a Location

Who is running the clinical trial?

Michael DonninoLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,779 Total Patients Enrolled
14 Trials studying Cardiac Arrest
30,105 Patients Enrolled for Cardiac Arrest
Michael W Donnino, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
8 Previous Clinical Trials
532 Total Patients Enrolled
3 Trials studying Cardiac Arrest
181 Patients Enrolled for Cardiac Arrest
~13 spots leftby Jun 2025
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