Trial Outcomes & Findings for Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia (NCT NCT02148809)

Results Overview

The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

preoperatively and 6 hours postoperatively

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Study 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1). Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine \> 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer. All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Study n=14 Participants 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1). Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine \> 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer. All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach.
Age, Continuous	63.8 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: preoperatively and 6 hours postoperatively

The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.

Outcome measures

Outcome measures
Measure	Pilot Study n=14 Participants 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1). Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine \> 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer. All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach.
Change in Total Blood Volume	487 ml Standard Deviation 455

OTHER_PRE_SPECIFIED outcome

Timeframe: preoperative and 6 hours postoperatively

An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370- 1,295 kBq \[10-30 mCi\]) in saline. Measurement was performed directly before surgery in the holding area and 6 hours after surgery. Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate.

Outcome measures

Outcome measures
Measure	Pilot Study n=14 Participants 14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1). Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine \> 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer. All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach.
Change IN Plasma Volume PV	214 ml Standard Deviation 324

Adverse Events

Pilot Study

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. Friedrich Boettner

HospitalSS

Phone: 2127742127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place