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NCT03313258: RUZIT
Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)
NA trial testing Standard of Care Group in Hypothermia. Withdrawn.
1 March 2019
Quick facts
| Lead sponsor | Dr. Asim Alam |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | prevention |
| Start date | 1 July 2018 |
| Primary completion | 1 March 2019 |
| Estimated completion | 31 May 2019 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Standard of Care Group
- Active Warming Group
Conditions studied
- Hypothermia — all drugs for Hypothermia →
- Trauma — all drugs for Trauma →
- Temperature Change, Body — all drugs for Temperature Change, Body →
Sponsor
Dr. Asim Alam
Who can join
18 and older, any sex, with Hypothermia or Trauma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03313258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Hypothermia
Currently open trials in the same condition.
- NCT07150559 — Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection · NA · recruiting
- NCT06485427 — Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke · NA · recruiting
- NCT06129825 — Pharmacologic Induction of Tolerance for Hypoxia & Hypothermia · active not recruiting
- NCT06250374 — Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endar · NA · active not recruiting
- NCT05170633 — Blood Warming in Preterm Infants to Decrease Hypothermia · NA · recruiting
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 NCT03313258 (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 Dr. Asim Alam
- Last refreshed: 28 February 2020
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/NCT03313258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing