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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
PROTEST Trial 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.Check my eligibility
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).See study design
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.
PROTEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a moderate brain injury, need a machine to help me breathe, and have bleeding in my brain.
Select...
My severe brain injury score is 8 or less.
Select...
I can start the trial medication within 3 days of my injury.
PROTEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically important VTE
Secondary outcome measures
180-day Mortality
30-day Mortality
7-day Mortality
+7 morePROTEST 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
656 Previous Clinical Trials
1,550,337 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,317 Total Patients Enrolled
Sunnybrook Research InstituteOTHER
31 Previous Clinical Trials
214,719 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a permanent blood clotting disorder.My weight is either below 45 kg or above 120 kg.I have an active, bleeding stomach or duodenal ulcer.I have a history of severe allergic reactions to heparin or positive tests for FRAGMIN.My blood pressure is very high despite taking medication.Something else, like drug side effects or a seizure, can explain why the person's level of consciousness is low.I do not have any uncontrollable bleeding.I have a moderate brain injury, need a machine to help me breathe, and have bleeding in my brain.I am 18 years old or older.I have been diagnosed with diabetic or hemorrhagic retinopathy.I cannot use compression devices on my leg due to my injuries.I have a known significant blood clotting disorder.I have been diagnosed with an infection in the inner lining of my heart.My severe brain injury score is 8 or less.I am allergic to FRAGMIN, heparins, or pork products.I can start the trial medication within 3 days of my injury.It is not expected that you will live for more than 48 hours after being admitted to the study.
Research Study Groups:
This trial has the following groups:- Group 1: Saline
- Group 2: Anticoagulant
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are taking part in this experiment?
"That is correct. The online clinicaltrials.gov database has the most recent information about this trial, which was first posted on July 19th, 2018 and edited on November 16th, 2020. They are looking for 1,100 individuals to participate at 12 different locations."
Answered by AI
Is Anticoagulant a risky medication for patients to take?
"Anticoagulant received a score of 3 because there is some evidence from past trials to support its efficacy and multiple rounds of data that suggest it is safe."
Answered by AI
What specific conditions does Anticoagulant help to improve?
"Anticoagulant medication can be used to treat a variety of issues like diarrhea, general surgery, and unstable angina pectoris."
Answered by AI
What other tests has Anticoagulant been involved in?
"Anticoagulant was first trialed in 2012 at Sieff Medical Center. In the 8 years since, there have been 921 completed studies with 119 active trials taking place around the world - many of them in Canada."
Answered by AI
Are we still enrolling people in this experiment?
"The trial is still recruiting patients, as seen on clinicaltrials.gov. The original posting date was July 19th, 2018 with the most recent edit taking place on November 16th, 2020."
Answered by AI
Could you please let me know how many different sites are conducting this research?
"Among other locations, this clinical trial is enrolling patients in Quebec at Hopital de L'Enfant-Jesus, Nova Scotia at Sunnybrook Health Science Centre, British Columbia at Queen Elizabeth II Health Sciences Centre, and Vancouver in Saskatchewan."
Answered by AI
Who else is applying?
What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
For the greater good of humanity is the main purpose. I have a traumatic brain injury and I need the money for out of pocket expenses.
PatientReceived no prior treatments
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