Authorised Therapeutic exploratory (Phase II) subarachnoid hemorrhage

ISCHEMIA

EU CTIS ID: 2024-511679-14-00

What this study is testing

Our primary objective is to evaluate whether aSAH patients treated with therapeutic dose LMWH have a lower 30-day mortality rate compared to aSAH patients treated with prophylactic dose LMWH.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA
  • Coiling of the causative aneurysm within 72 hours of initial SAH
  • Informed consent before the first scheduled administration of the study medicine
  • Adult age (≥18 years)

You likely can't join if

  • Stent-assisted coiling
  • Use of anticoagulant or dual antiplatelet medication post-coiling for other reasons
  • Incomplete aneurysm occlusion/partial coiling
  • Intraparenchymal hemorrhage
  • Pregnancy
  • Contra-indications for LMWH: o Previous history of history of heparin-induced thrombocytopenia o (Suspicion of) active arterial or venous bleeding o Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation) o Severe hypertension: uncontrolled hypertension with a MAP > 135mmHg o Previous history of hypertensive or diabetic retinopathy o Previous history of active infectious endocarditis o Severe renal impairment (creatinine clearance <30 mL / min)
See the full eligibility criteria
Who can join
  • SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA
  • Coiling of the causative aneurysm within 72 hours of initial SAH
  • Informed consent before the first scheduled administration of the study medicine
  • Adult age (≥18 years)
What rules you out
  • Stent-assisted coiling
  • Use of anticoagulant or dual antiplatelet medication post-coiling for other reasons
  • Incomplete aneurysm occlusion/partial coiling
  • Intraparenchymal hemorrhage
  • Pregnancy
  • Contra-indications for LMWH: o Previous history of history of heparin-induced thrombocytopenia o (Suspicion of) active arterial or venous bleeding o Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation) o Severe hypertension: uncontrolled hypertension with a MAP > 135mmHg o Previous history of hypertensive or diabetic retinopathy o Previous history of active infectious endocarditis o Severe renal impairment (creatinine clearance <30 mL / min)
  • No proficiency of Dutch or English language
  • Proven and active COVID-19 infection

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.