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Anticoagulant

Dalteparin for Traumatic Brain Injury (PROTEST Trial)

Phase 3
Recruiting
Led By Farhad Pirouzmand, MD, MSc, FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
Patients with moderate TBI defined as GCS = 9-12, admitted to ICU, with at least some ICB present on initial CT scan and requiring invasive mechanical ventilation at the time of screening or increased ICB on repeat CT scan compared to initial CT scan
Must not have
Known presence of irreversible coagulopathies
Participants extremely low weight (<45 kg), or extremely high weight (>120kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
Pivotal Trial
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is testing a new treatment for people with traumatic brain injuries. The trial is double-blind, meaning that neither the patients nor the doctors know who is receiving the new treatment.

Who is the study for?
This trial is for adults over 18 with severe to moderate traumatic brain injury (TBI), evidenced by a Glasgow Coma Scale score of ≤12, who are in ICU and need mechanical ventilation. They must be able to start the treatment within 3 days of injury. Excluded are those with hypersensitivity to Dalteparin or pork products, certain blood disorders, uncontrollable bleeding, extreme weights (<45kg or >120kg), or other factors affecting consciousness.
What is being tested?
The PROTEST study is testing the effectiveness of Dalteparin versus Saline in preventing blood clots in patients with severe TBI. It's a phase III trial where participants are randomly assigned to receive either Dalteparin or Saline without knowing which one they're getting (double blind).
What are the potential side effects?
Dalteparin may cause side effects like bleeding, pain at injection site, allergic reactions, and possibly heparin-induced thrombocytopenia—a serious condition where platelets drop leading to more clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a moderate brain injury, need a machine to help me breathe, and have bleeding in my brain.
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My severe brain injury score is 8 or less.
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I can start the trial medication within 3 days of my injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a permanent blood clotting disorder.
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My weight is either below 45 kg or above 120 kg.
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I have an active, bleeding stomach or duodenal ulcer.
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I have a history of severe allergic reactions to heparin or positive tests for FRAGMIN.
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My blood pressure is very high despite taking medication.
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I have been diagnosed with diabetic or hemorrhagic retinopathy.
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I do not have any uncontrollable bleeding.
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I cannot use compression devices on my leg due to my injuries.
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I have a known significant blood clotting disorder.
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I have been diagnosed with an infection in the inner lining of my heart.
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I am allergic to FRAGMIN, heparins, or pork products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinically important VTE
Secondary study objectives
180-day Mortality
30-day Mortality
7-day Mortality
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AnticoagulantActive Control1 Intervention
Dalteparin sodium (at a dose of 5000 IU once daily by subcutaneous injection) for 7 days upon randomization after hospital admission.
Group II: SalinePlacebo Group1 Intervention
Saline (0.2 mL) once daily by subcutaneous injection for 7 days upon randomization after hospital admission.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,564,389 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,516,973 Total Patients Enrolled
Sunnybrook Research InstituteOTHER
31 Previous Clinical Trials
214,685 Total Patients Enrolled

Media Library

Dalteparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03559114 — Phase 3
Traumatic Brain Injury Research Study Groups: Saline, Anticoagulant
Traumatic Brain Injury Clinical Trial 2023: Dalteparin Highlights & Side Effects. Trial Name: NCT03559114 — Phase 3
Dalteparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03559114 — Phase 3
~264 spots leftby Dec 2026
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