Postoperative Pericardial Flush, to evaluate the effects of pericardial flush with a crystalloid on blood loss after CABG.

Postoperative Pericardial Flush, to evaluate the effects of pericardial flush with a crystalloid on blood loss after CABG. - Postoperative Pericardial Flush (CABG)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44986

Enrollment

180

Registered

2013-05-17

Start date

2014-01-15

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

blood loss transfusion requirements

Interventions

Postoperative Pericardial Flush (PPF) system The PPF system is aimed to extract the contaminated pericardial blood, dilute thrombi, decrease postoperative blood loss, and prevent the formation of po

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All adult patients (>18y) undergoing surgery for CABG.

Exclusion criteria

Exclusion criteria: - Previous CABG; - Emergency surgery; - Preoperative use of Dabigatran, Rivaroxaban, Apixaban, Clopidogrel, Brilique or Prasugrel; - Participation in any study involving an investigational drug or device; - Age

Design outcomes

Primary

Measure	Time frame
To determine whether postoperative pericardial flush with a crystalloid can reduce postoperative blood loss by effectively removing contaminated pericardial blood after CABG. The primary study endpoints include: blood loss 12h postoperative and delta haemoglobin (between sternal closure and 12h postoperative).	—

Secondary

Measure	Time frame
All secondary study parameters are derived from standard patient monitoring data; therefore no extra provisions are needed. ICU - GENERAL: aBP, dBP, patient rectal/core temperature (°C), mechanical ventilation duration (hours), bairhugger use (hours), removal of chest tubes (hours postoperative), ICU stay (days). - TRANSFUSION: pumpblood (mL), RBC, platelets (units), plasma (units), fibrinogen (mg), cofact (IE) , novo7 (ml); - LAB: CRP, leukocytes, pH, platelets, INR, haemoglobin (T24), haemotocrit, CKMB; - ECG: AF, VT/VF, SVT, AV-Blok, >QRS, MI; - MEDICATION: AF conversion medication, AF conversion success, antibiotics; - COMPLICATIONS: early (	—

Measure

Time frame

All secondary study parameters are derived from standard patient monitoring data; therefore no extra provisions are needed. ICU - GENERAL: aBP, dBP, patient rectal/core temperature (°C), mechanical ventilation duration (hours), bairhugger use (hours), removal of chest tubes (hours postoperative), ICU stay (days). - TRANSFUSION: pumpblood (mL), RBC, platelets (units), plasma (units), fibrinogen (mg), cofact (IE) , novo7 (ml); - LAB: CRP, leukocytes, pH, platelets, INR, haemoglobin (T24), haemotocrit, CKMB; - ECG: AF, VT/VF, SVT, AV-Blok, >QRS, MI; - MEDICATION: AF conversion medication, AF conversion success, antibiotics; - COMPLICATIONS: early (

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)