Haemoconcentration of cardiopulmonary bypass blood with Hemosep

A randomised controlled pilot study comparing standard fluid management with haemoconcentration of remaining cardiopulmonary bypass blood using the new Hemosep device

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51513145

Enrollment

Registered

2014-02-18

Start date

2013-11-04

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular

Interventions

Hemosep device vs standard care in the peri-operative period Haemoconcentration of remaining blood from cardiopulmonary bypass machine. Study Entry : Single Randomisation only

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective or urgent coronary artery bypass graft surgery (CABG), heart valve surgery, or a combination of CABG and valve surgery will be included.; Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion criteria

Exclusion criteria: 1. Patients under 18 years of age 2. Patients undergoing emergency surgery 3. Patients with a contraindication to either heparin, protamine or tranexamic acid 4. Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs

Design outcomes

Primary

Measure	Time frame
Haematocrit; Timepoint(s): 30-60 minutes after transfusion of blood	—

Secondary

Measure	Time frame
1. To evaluate the efficacy of the Hemosep system in reducing allogenic blood transfusion in patients post CPB for cardiac surgery 2. To compare the early postoperative serum levels of red cells, platelets and leukocytes between conventionally treated patients and patients treated with the Hemosep system 3. To compare the early postoperative coagulation indices, clotting factor levels and platelet count between patients treated conventionally and patients treated with the Hemosep system 4. To evaluate the cost effectiveness of the Hemosep system in patients undergoing cardiac surgery	—

Measure

Time frame

1. To evaluate the efficacy of the Hemosep system in reducing allogenic blood transfusion in patients post CPB for cardiac surgery 2. To compare the early postoperative serum levels of red cells, platelets and leukocytes between conventionally treated patients and patients treated with the Hemosep system 3. To compare the early postoperative coagulation indices, clotting factor levels and platelet count between patients treated conventionally and patients treated with the Hemosep system 4. To evaluate the cost effectiveness of the Hemosep system in patients undergoing cardiac surgery

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026