NCT Number: NCT06332547
This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510145, China
He Biaochuan, Phd
PRINCIPAL_INVESTIGATOR
Huang Huanlei, Phd
CONTACT
Huang huanlei, Phd
PRINCIPAL_INVESTIGATOR
Wang Qiuji, MD
PRINCIPAL_INVESTIGATOR
Wang Zhenzhong, MD
PRINCIPAL_INVESTIGATOR
Zhang Zhaolong, BD
PRINCIPAL_INVESTIGATOR
Zhao Junfei, Phd
PRINCIPAL_INVESTIGATOR
Patients are randomly assigned to restrictive-threshold group and liberal-threshold group before cardiac group. Patients are included in this research when their Hct meets 24% during CPB.
Arterial blood gas analysis will be done in 0.5h, 1.5h, 2.5h, 3.5h...after CPB start and 0.5h before CPB finish.
Arterial blood gas analysis will be done every 4h in intensive care unit(ICU) and everyday in general ward.
Restrictive-threshold group: The transfusion threshold is Hemoglobin(Hb) ≤ 6.0g/dL or Hct ≤ 18% during CPB; postoperative Hb ≤ 7.0g/dL or Hct ≤ 21% in ICU or general ward.
Liberal-threshold group: The transfusion threshold is Hb ≤ 8.0g/dL or Hct ≤ 24% during CPB; postoperative Hb ≤ 10.0g/dL or Hct ≤ 30% in ICU or general ward.
If the Hb or Hct fall below the threshold at any time, 2 unit of blood cells is administered as soon as possible. Test Hb or Hct again, if is under the threshold 2 unit blood cells will be given until reach the threshold.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood transfusion at HCT less than 21% or Hb less than 6.0g/dL during CPB, at HCT less than 21% or Hb less than 7.0g/dL in ICU or general ward after surgery
Blood transfusion at HCT less than 24% or Hb less than 8.0g/dL during CPB, at HCT less than 30% or Hb less than 10.0g/dL in ICU or general ward after surgery
Time frame: Postoperative 6 months
The composite components are postoperative mortality, infectious morbidity(wound infection, septicemia, or sepsis), ischemic event(myocardial infarction, stroke, renal infraction, bowel infraction )
Time frame: Postoperative 6 months
Time frame: From date of the end of operation until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.
Time frame: From date of discharging from ICU until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 2 months.
Time frame: From date of beginning of surgery until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months.
Time frame: From date of the end of surgery until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.
Time frame: The first 24 hours after surgery
Time frame: Postoperative 6 months
Time frame: Postoperative 6 months
Time frame: Postoperative 6 months
Time frame: Postoperative 6 months
Time frame: From date of being admitted to hospital until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months
Contact information is provided by the study sponsor or research team.
Huang Huanlei, Phd
CONTACT
Zhang Zhaolong, BD
CONTACT
Guangdong Provincial People's Hospital
Other
A Multicenter Prospective, Randomized Controlled Study of Different Transfusion Thresholds in Cardiac Valve Surgery
Acronym: TICVS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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