Trial Outcomes & Findings for Association of Anemia With Hospital Costs in Elective Colorectal Surgery (NCT NCT03476707)

NCT ID: NCT03476707

Last Updated: 2024-09-24

Results Overview

Direct and indirect costs accrued during the index hospitalization. Costs were measured using standard and validated algorithms, standardized to 2016 CAD. This method accounts for a patient's resource intensity weight, their case mix group, as well as fixed patient costs (e.g., medications, investigations) and indirect costs to the hospital based on patient's location of care (intensive care unit versus ward) and length of stay.

• Recruitment status: COMPLETED
• Target enrollment: 851 participants
• Primary outcome timeframe: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
• Results posted on: 2024-09-24

Participant Flow

Participant milestones

Measure	Anemic People with a preoperative hematocrit less than 0.39 Anemia: Hematocrit less than 0.39	Non-anemic People with a preoperative hematocrit greater than or equal to 0.39
Overall Study STARTED	381	470
Overall Study COMPLETED	381	470
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Association of Anemia With Hospital Costs in Elective Colorectal Surgery

Baseline characteristics by cohort

Measure	Anemic n=381 Participants People with a preoperative hematocrit less than 0.39 Anemia: Hematocrit less than 0.39	Non-anemic n=470 Participants People with a preoperative hematocrit greater than or equal to 0.39	Total n=851 Participants Total of all reporting groups
Age, Customized Age · < 65	123 Participants n=5 Participants	272 Participants n=7 Participants	395 Participants n=5 Participants
Age, Customized Age · 65-74	105 Participants n=5 Participants	117 Participants n=7 Participants	222 Participants n=5 Participants
Age, Customized Age · 75-84	114 Participants n=5 Participants	67 Participants n=7 Participants	181 Participants n=5 Participants
Age, Customized Age · >84	39 Participants n=5 Participants	14 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Female	214 Participants n=5 Participants	181 Participants n=7 Participants	395 Participants n=5 Participants
Sex: Female, Male Male	167 Participants n=5 Participants	289 Participants n=7 Participants	456 Participants n=5 Participants
Independent Functional Status	353 Participants n=5 Participants	467 Participants n=7 Participants	820 Participants n=5 Participants
Elixhauser comorbidity index	6.16 Index STANDARD_DEVIATION 5.98 • n=5 Participants	5.50 Index STANDARD_DEVIATION 5.89 • n=7 Participants	6 Index STANDARD_DEVIATION 6 • n=5 Participants
Procedural Index for Mortality Risk (PIMR) Score	0.47 Number of procedural risk points STANDARD_DEVIATION 1.39 • n=5 Participants	0.17 Number of procedural risk points STANDARD_DEVIATION 0.70 • n=7 Participants	0.3 Number of procedural risk points STANDARD_DEVIATION 1.1 • n=5 Participants
American Society of Anesthesiology (ASA) Score I-II	51 Participants n=5 Participants	142 Participants n=7 Participants	193 Participants n=5 Participants
American Society of Anesthesiology (ASA) Score III	260 Participants n=5 Participants	302 Participants n=7 Participants	562 Participants n=5 Participants
American Society of Anesthesiology (ASA) Score IV-V	70 Participants n=5 Participants	26 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first

Direct and indirect costs accrued during the index hospitalization. Costs were measured using standard and validated algorithms, standardized to 2016 CAD. This method accounts for a patient's resource intensity weight, their case mix group, as well as fixed patient costs (e.g., medications, investigations) and indirect costs to the hospital based on patient's location of care (intensive care unit versus ward) and length of stay.

Outcome measures

Measure	Anemic n=381 Participants People with a preoperative hematocrit less than 0.39 Anemia: Hematocrit less than 0.39	Non-anemic n=470 Participants People with a preoperative hematocrit greater than or equal to 0.39
Total Hospital Costs	23,667 Dollars Standard Deviation 32,210	17,100 Dollars Standard Deviation 10,822

SECONDARY outcome

Timeframe: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)

Number of days in hospital after surgery

Outcome measures

Measure	Anemic n=381 Participants People with a preoperative hematocrit less than 0.39 Anemia: Hematocrit less than 0.39	Non-anemic n=470 Participants People with a preoperative hematocrit greater than or equal to 0.39
Length of Stay	12.4 Days Standard Deviation 17.5	8.5 Days Standard Deviation 7.5

SECONDARY outcome

Timeframe: Hospital admission to date of surgery, or 365 days after admission, whichever came first

Any red blood cell transfusion received

Outcome measures

Measure	Anemic n=381 Participants People with a preoperative hematocrit less than 0.39 Anemia: Hematocrit less than 0.39	Non-anemic n=470 Participants People with a preoperative hematocrit greater than or equal to 0.39
Red Blood Cell Transfusion	88 Participants	18 Participants

Adverse Events

Anemic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-anemic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel McIsaac

The Ottawa Hospital

Phone: 613-761-4940

Email: dmcisaac@toh.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place