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NCT03687541: HEMO-CIH
In-hospital Falls and Hemorrhagic Complications : a Descriptive Analysis in Rennes University Hospital
trial in In-hospital Falls in 157 participants. Completed in 10 October 2018.
10 October 2018
Quick facts
| Lead sponsor | Rennes University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 157 |
| Start date | 7 September 2018 |
| Primary completion | 10 October 2018 |
| Estimated completion | 10 October 2018 |
| Sites | 1 location across France |
Conditions studied
- In-hospital Falls — all drugs for In-hospital Falls →
Sponsor
Rennes University Hospital
Who can join
18 and older, any sex, with In-hospital Falls. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anticoagulant and antiplatelet treatments have well defined indactions, with a clearly proved benefit, respectivly for prevention of arterial and venous emblism and for prevention of athermo-related arterial thrombosis. Bleeding risk represents the main adverse effect of these antithrombotic medications. Then benefit-risk ratio is sometimes difficult to evaluate, especially for elderly patients prone to fall (incidence of falls estimated to 30% per year for patients over 65), exposed on the one hand to thromboembolic risk and on the other hand to bleeding risk. Associations between falls and antithrombotic-related bleeding risk had already been evaluated in several studies : * Concerning anticoagulant treatments in patients at high risk of falls, retrospective studies shown a overrated risk of intracranial hemorrhage and mortality, but those results remain discordant wtih 3 major prospective studies on larger populations. * Concerning antiplatelet treatments in patients at high risk of falls, majority of retrospective studies reported an overrated risk of major bleeding, intracranial bleeding and mortality, but datas remain fewer than for anticoagulant and results are as well discordant with prospective studies. * No difference of morbi-mortality is clearly estalblished depending of antithrombotic treatment class (anticoagulant versus antiplatelet), however there is a cumulative risk in case of association of both anticoagulant and antiplatelet. * Main factors associated with fall-related bleeding for patients on anticoagulant include age, female sex, anemia, chronic kidney disease, dementia and polymedication. Thus, the purpose of this study is to specify whether occurrence of falls justify to reconsider prescription of antithrombotic treatments in patients having an indication of antiplatelet or anticoagulant therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03687541
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03687541 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rennes University Hospital
- Last refreshed: 19 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03687541.
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