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NCT04826666: TOF_PHLEBO
Intraoperative Phlebotomies and Bleeding in Liver Transplantation
trial in Liver Diseases in 679 participants. Completed in 4 November 2021.
4 November 2021
Quick facts
| Lead sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 679 |
| Start date | 31 March 2021 |
| Primary completion | 4 November 2021 |
| Estimated completion | 4 November 2021 |
| Sites | 1 location across Canada |
Conditions studied
- Liver Diseases — all drugs for Liver Diseases →
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
- Surgery — all drugs for Surgery →
- Surgery--Complications — all drugs for Surgery--Complications →
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Who can join
Eligibility, any sex, with Liver Diseases or Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery. To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intraoperative phlebotomies and bleeding in liver transplantation: a historical cohort study and causal analysis.
Carrier FM, Ferreira Guerra S, Coulombe J, Amzallag É, et al · · 2022 · cited 5× · PMID 35112303 · DOI 10.1007/s12630-022-02197-1
Verify or expand the search:
- PubMed search for NCT04826666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04826666 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM)
- Last refreshed: 9 November 2021
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