NCT00299416

Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia

Completed Phase 1/Phase 2 Results posted Last updated 5 April 2011

What this trial tests

Phase 1/Phase 2 trial testing Caffeinol in Acute Ischemic Stroke in 30 participants. Completed in 1 August 2009.

Timeline

1 February 2003

Primary endpoint
1 January 2009

1 August 2009

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 February 2003
Primary completion	1 January 2009
Estimated completion	1 August 2009
Sites	1 location across United States

Drugs / interventions tested

• Caffeinol — full drug profile →
• hypothermia

Conditions studied

• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 80, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Symptomatic Intracerebral Hemorrhage
  Time frame: from pre-dosage to 90 day followup
  Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol \& hypothermia,at the end of hypothermia \& rewarming, 24 hrs after stroke onset, daily during hospitalization,\& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period \& 12 hr rewarming period. At the end of rew
• Number of Participants With Catheter Related Complications During Hypothermia & Rewarming
  Time frame: over 36 hour period
  Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.
• Number of Participants With Cardiorespiratory Failure
  Time frame: every 30 minutes during hypothermia induction
  The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.

Sponsor's own description

Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase I and Phase II Therapies for Acute Ischemic Stroke: An Update on Currently Studied Drugs in Clinical Research.
   Reis C, Akyol O, Ho WM, Araujo C, et al · · 2017 · cited 31× · PMID 28286764 · DOI 10.1155/2017/4863079
2. Intertwined Relation between the Endoplasmic Reticulum and Mitochondria in Ischemic Stroke.
   Peng J, Ghosh D, Pang J, Zhang L, et al · · 2022 · cited 8× · PMID 35528523 · DOI 10.1155/2022/3335887