Postoperative Pericardial Flush, to evaluate the effects of pericardial flush with a crystalloid on blood loss after valvular surgery and correction for CHD.

Postoperative Pericardial Flush, to evaluate the effects of pericardial flush with a crystalloid on blood loss after valvular surgery and correction for CHD. - Postoperative Pericardial Flush (CHD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39811

Enrollment

170

Registered

2013-02-15

Start date

2013-05-08

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

The Pericardial Flush system is aimed to extract the contaminated pericardial blood, dilute thrombi, decrease postoperative blood loss, and prevent the formation of postoperative pericardial adhesio

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All adults undergoing surgery for CHD. - All adults undergoing valvular surgery.

Exclusion criteria

Exclusion criteria: - Emergency surgery; - Myopathia; - Indication for treatment with statins based on the CBO-guideline for cardiovascular risk management; - Participation in any study involving an investigational drug or device; -

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: - The difference in haemoglobin levels between T-1 (start PPS) and T12 (12 hours postoperative) (*Hb); - Thoracic drain production 12 hours postoperatively (ml).	—

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), packed cells (units), filtered erythrocytes (units), platelets (units), plasma (units), fibrinogen (mg), cofact (IE) , novo7 (ml); - LAB: CRP, leukocytes, pH, platelets, INR, haemoglobin, 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), packed cells (units), filtered erythrocytes (units), platelets (units), plasma (units), fibrinogen (mg), cofact (IE) , novo7 (ml); - LAB: CRP, leukocytes, pH, platelets, INR, haemoglobin, 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)