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IMPROVING OUTCOME IN SUBARACHNOID HEMORRHAGE WITH NADROPARINE

IMPROVING OUTCOME IN SUBARACHNOID HEMORRHAGE WITH NADROPARINE - ISCHEMIA

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54629
Enrollment
100
Registered
2021-06-04
Start date
2022-02-03
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke subarachnoïd hemorrhage

Interventions

Therapeutic dose of nadroparine (5700IE twice daily), continued until 21 days after initial SAH or untill discharge, compared to a standard profylactic dose (2850IE once daily).

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients suffering from an aneurysmal subarachnoid hemorrhage treated with coiling.

Exclusion criteria

Exclusion criteria: Stent-assisted coiling Contra-indications low-molecular weight heparin Proven and active COVID-19

Design outcomes

Primary

MeasureTime frame
30-days mortality

Secondary

MeasureTime frame
To evaluate whether there is a difference in: • patients with a favourable outcome (score 0-3 on the mRS) after six months • quality of life after three and six months • cognitive functioning at three and six months after hemorrhage • the presence and severity of delayed cerebral is-chemia • the presence of cerebral (micro)infarctions on MR-imaging six months after hemorrhage • the rate of a major and non-major bleeding • the presence of major or clinically relevant non-major hemorrhagic complications after EVD/ELD placement or LP • the occurrence of venous thrombo-embolic events • the hemostatic balance and markers of activation of coagulation • markers of inflammation and coagulation • discharge destination • shunt-dependent hydrocephalus • other SAH-related complications (such as severe hyponatriaemia, delayed cerebral ischemia, postprocedural aneurysm rupture, rebleed, delirium, epilepsy, diffuse parenchymal swelling or nosocomial infections) during admission

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)