Health TrialsbyHealthPanel

Transfusion in Cardiac Valve Surgery

ConditionsCardiac Surgery With Cardiopulmonary BypassValve Heart Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangdong Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained

Disqualifiers

Pregnant or maternal women Age less than 18 years or more than 80 years Undergo coronary artery bypass or large cardiac vessels procedure Emergencies Have been attended other researches Unable to receive blood for religious reasons Drug addict or malignant tumor patient

Trial design

Design model

Parallel

Treatments tested in this trial

  • Restrictive Transfusion Strategy

    Other intervention

    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

  • Liberal Transfusion Strategy

    Other intervention

    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

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: Restrictive transfusion strategyActive comparator 1 intervention
Group B: Liberal Transfusion StrategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

A composite of postoperative morbidity and mortality

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

Secondary outcomes

1

Rate of reoperation

Time frame
Postoperative 6 months
2

Length of ICU Stays

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.
3

Length of Postoperative Hospital Stay

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.
4

Number of Blood Transfusion

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: