Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion (TANDEM-1)
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ClinicalTrials.gov Identifier: NCT00777140 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : July 6, 2012
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Iron overload has been associated with greater brain injury in ischemia/reperfusion experimental stroke models and ischemic stroke patients, especially in those treated with thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a neuroprotective action in ischemia/reperfusion animal models.
Primary objective: To evaluate the security and tolerability of deferoxamine endovenous treatment in acute ischemic stroke patients treated with iv. tPA.
Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10 mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation and brain edema development.
Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be increased according to security results of the previous stage. Patients will be continuously monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and 30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine concentrations will be measured along time after the injection in a subgroup of patients to the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic transformation and brain edema. The NIH Stroke Scale will be evaluated during hospitalization, and the Rankin score at discharge and 3 months.
If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke patients, it may be a new therapy option to lower the brain injury after ischemia and reperfusion.
Condition or disease | Intervention/treatment | Phase |
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Acute Ischemic Stroke | Drug: Deferoxamine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-blind, Randomized, Placebo Controlled, Dose-finding Phase 2 Clinical Trial of Intravenous Deferoxamine in Patients With Acute Ischemic Stroke Treated With Tissue Plasminogen Activator |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
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Active Comparator: 1. Deferoxamine
Intravenous deferoxamine: bolus of 10mg/Kg (initiated during tPA infusion) and perfusion of 20/40/60 mg/Kg/day during 72h. Three different doses (3 steps), 15 patient in the active arm for each dose.
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Drug: Deferoxamine
Intravenous deferoxamine: bolus 10mg/Kg (initiated during thrombolytic infusion, iv tPA), followed by intravenous perfusion of 20/40/60mg/Kg during 72h. It's a dose-finding study with 3 different doses of deferoxamine, with 20 patients (15 active:5 placebo) in each step. Bolus + 72h perfusion of saline solution for the placebo group. |
Placebo Comparator: 2. Placebo
Saline solution: Bolus and perfusion during 72h. 5 patients in the placebo arm in each step (randomization 3:1)
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Drug: Deferoxamine
Intravenous deferoxamine: bolus 10mg/Kg (initiated during thrombolytic infusion, iv tPA), followed by intravenous perfusion of 20/40/60mg/Kg during 72h. It's a dose-finding study with 3 different doses of deferoxamine, with 20 patients (15 active:5 placebo) in each step. Bolus + 72h perfusion of saline solution for the placebo group. |
- Clinical and Analytical Adverse Events (anemia, hypotension, renal failure, mortality, hemorrhagic transformation, cerebral edema, other severe adverse events) [ Time Frame: 3 months ]
- Neurological status (NIHSS, Barthel and Rankin scales), final ischemic lesion volume on CTscan. [ Time Frame: 24h, 7days and 3 months ]
- Deferoxamine and ferritin levels in serum (pharmacokinetics). [ Time Frame: 72h ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-80 years old
- Acute Ischemic Stroke on the middle cerebral artery territory
- Treatment with iv tPA in the first 3 hours from symptoms onset
Exclusion Criteria:
- Modified Rankin Scale more or equal to 2
- Infectious, inflammatory, neoplastic or hematologic disease
- Anemia (Hto<34% or Hb<10g/dl)
- Previous renal failure
- Previous treatment with oral iron supplement
- Minor stroke (NIHSS less than 4), lacunar or posterior territory
- Alcohol consumption (more than 40mg/Kg)
- Pregnancy
- Participation in other clinical trials

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777140
Spain | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Hospital Clínico Universitario de Santiago de Compostela | |
Santiago de Compostela, La Coruña, Galicia, Spain, 15706 | |
Hospital Universitari Josep Trueta | |
Girona, Spain, 17007 | |
Hospital Universitario de la Princesa | |
Madrid, Spain, 28006 |
Principal Investigator: | Monica Millán Torné, MD | Germans Trias i Pujol Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Monica Millan Torne, Medical Doctor, Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00777140 |
Other Study ID Numbers: |
TANDEM-1 EUDRACT: 2007-006731-31 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | July 6, 2012 |
Last Verified: | July 2012 |
Stroke Ischemic Stroke Thrombolytic treatment Middle cerebral artery occlusion |
Deferoxamine Iron chelator Acute Ischemic Stroke treated with Intravenous Thrombolytic |
Stroke Infarction, Middle Cerebral Artery Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Cerebral Infarction |
Brain Infarction Brain Ischemia Cerebral Arterial Diseases Intracranial Arterial Diseases Deferoxamine Siderophores Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |