Cognitive function and surgical success following pulmonary endarterectomy. A randomised controlled trial to compare deep hypothermic circulatory arrest with selective anterograde cerebral perfusion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84972261

Enrollment

110

Registered

2007-09-28

Start date

2006-09-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Endarterectomy Surgery Endarterectomy

Interventions

Minor additions made to interventions on 25/04/2008 (noted in text): We propose to perform a prospective, single centre, randomised study to include all patients referred to Papworth Hospital for PEA

Eligibility

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 25/04/2008: 1. Patients referred for PEA 2. Aged between 18 and 80, either sex 3. Written informed consent obtained Previous inclusion criteria: All patients referred to Papworth hospital for PEA

Exclusion criteria

Exclusion criteria: Added 25/04/2008: 1. Anticipated difficulty with completion of cognitive function tests (e.g. sight or hearing impairments, physical barriers) 2. Not fluent in the English language 3. Unable to obtain informed consent 4. Patients having other concomitant surgery, e.g. coronary artery bypass grafting, valve surgery 5. Past medical history of stroke or psychiatric disorder 6. Repeat PEA 7. Patients having unacceptable risk as per investigator judgement or where a specific request for either DHCA or SACP has been made by the surgeon

Design outcomes

Primary

Measure	Time frame
The proportion of patients demonstrating a decline in cognitive function, compared to baseline, 12 weeks after PEA in DHCA versus SACP groups. Cognitive function will be assessed using the consensus battery of conventional pen and paper tests.	—

Secondary

Measure	Time frame
Added as of 25/04/2008: 1. The number of patients with clinically significant cognitive function deficit at twelve weeks, defined as a drop in a patient's postoperative score of greater than or equal to 1 SD from their pre-operative score in two or more tests 2. Mean pulmonary artery pressure (mPAP) and pulmonary vascular resistance (PVR) at baseline and 12 weeks post-surgery 3. NYHA, CAMPHOR and six-minute walk test at baseline, 12 weeks, and 1 year 4. Cognitive function in patients 12 months after PEA assessed as detailed above 5. CANTAB system of computerised cognitive tests at baseline, 12 weeks and 1 year 6. Extubation time 7. Length of stay in the Intensive Care Unit and in hospital 8. Intra-operative cerebral oxygen saturation as measured by near infrared spectroscopy (NIRS)	—

Measure

Time frame

Added as of 25/04/2008: 1. The number of patients with clinically significant cognitive function deficit at twelve weeks, defined as a drop in a patient's postoperative score of greater than or equal to 1 SD from their pre-operative score in two or more tests 2. Mean pulmonary artery pressure (mPAP) and pulmonary vascular resistance (PVR) at baseline and 12 weeks post-surgery 3. NYHA, CAMPHOR and six-minute walk test at baseline, 12 weeks, and 1 year 4. Cognitive function in patients 12 months after PEA assessed as detailed above 5. CANTAB system of computerised cognitive tests at baseline, 12 weeks and 1 year 6. Extubation time 7. Length of stay in the Intensive Care Unit and in hospital 8. Intra-operative cerebral oxygen saturation as measured by near infrared spectroscopy (NIRS)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026