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NCT01444508
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Phase 4 trial testing Ringer-lactate "SAD" in Bloodloss in 40 participants. Status unknown.
1 April 2013
Quick facts
| Lead sponsor | K. C. Rasmussen |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 1 September 2011 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 December 2013 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Ringer-lactate "SAD" — full drug profile →
- HES 130/04 — full drug profile →
Conditions studied
- Bloodloss — all drugs for Bloodloss →
Sponsor
K. C. Rasmussen — full company profile →
Who can join
18 and older, any sex, with Bloodloss. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Effect of colloid versus crystalloid on laboratory coagulation.
Time frame: 5-7 hours
Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.
Sponsor's own description
In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01444508
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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- medRxiv preprints
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Related trials
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 NCT01444508 (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 K. C. Rasmussen
- Last refreshed: 12 December 2013
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/NCT01444508.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing