Phase 2
Completed N=38
A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty
Source: ClinicalTrials.gov NCT03981419 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Effect of GRF6021 on Immune Responses to Surgery as Determined by Cytometry by Time of Flight (CyTOF) on Day 2 — 0.5692; 0.4521; 0.5326; 0.4471 predicted value
Summary
This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery parameters in participants undergoing primary hip or knee arthroplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of GRF6021 on Immune Responses to Surgery as Determined by Cytometry by Time of Flight (CyTOF) on Day 2 |
0.5692; 0.4521; 0.5326; 0.4471 | — |
| PRIMARY Effect of GRF6021 on Immune Responses to Surgery as Determined by Cytometry by Time of Flight (CyTOF) on Day 3 |
0.7829; 0.2871 | — |
| SECONDARY Change in Functional Status Using the ActiGraph Wearable Device Providing Measurements for Physical Activity/Function and Sleep |
1.7007; 1.3861 | — |
| SECONDARY Effects of GRF6021 on Plasma Proteomics |
1.4320; 1.3716; 1.4189; 1.5245; 1.1563; 1.7264 | — |
| SECONDARY Number of Participants With Change From Baseline in Delirium as Assessed Using 3-Minute Diagnostic Interview for Confusion Assessment Method (3-Minute Diagnostic Interview for Confusion [3D-CAM]) |
0; 0; 18; 19; 2; 0 | — |
| SECONDARY Time to 50% Recovery of Baseline Value on the Surgery Recovery Scale (SRS) |
11.5; 15.0 | — |
| SECONDARY End of Study (EOS) Treatment Comparison of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
28.50; 37.30 | — |
| SECONDARY Time to a Score of < 12/40 on a Subset of Questions From the WOMAC, Pain Subscale |
13.5; 16.0 | — |
| SECONDARY Time to a Score of < 18/60 on a Subset of Questions From the WOMAC, Physical Function Subscale |
18.0; 18.0 | — |
| SECONDARY Change From Baseline in Mental Health Score in the Short Form-36 (SF-36) |
56.7; 57.6; 2.1; 0.8 | — |
| SECONDARY Change From Baseline in Physical Health Score in the SF-36 |
32.7; 34.9; 4.0; 3.3 | — |
| SECONDARY Change From Baseline in the Beck Depression Inventory-II (BDI-II) |
7.3; 5.1; -3.2; -2.7 | — |
| SECONDARY Number of Participants With Opioid Analgesic Consumption During Hospital Stay and After Discharge to End of Study |
18; 19 | — |
| SECONDARY Time to Discharge |
2.0; 2.0 | — |
| SECONDARY Perioperative Outcome: Surgery Duration |
1.8; 1.6 | — |
| SECONDARY Perioperative Outcome: Duration for Which Participants Were Under Anesthesia |
3.0; 2.7 | — |
| SECONDARY Perioperative Outcome: Duration of Stay in the Post-Anesthesia Care Unit (PACU) |
2.6; 2.9 | — |
| SECONDARY Perioperative Outcome: Number of Participants in Each 5 American Society of Anesthesiologists (ASA) Class |
0; 0; 8; 12; 10; 7 | — |
| SECONDARY Perioperative Outcome: Estimated Blood Loss |
113.6; 135.8 | — |
| SECONDARY Number of Participants in Whom Intraoperative Fluids Were Administered |
0; 0 | — |
| SECONDARY Number of Participants in Whom Intraoperative Blood Products Were Administered |
0; 0 | — |
| SECONDARY Number of Participants Who Received Intraoperative Anesthesia |
18; 19; 15; 19 | — |
| SECONDARY Number of Participants Who Received Intraoperative Opioids |
17; 19; 9; 6; 2; 3 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Blood Chemistry Values |
1; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Hematology Values |
6; 1; 8; 4; 3; 3 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Coagulation Values |
1; 1; 1; 0; 0; 2 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Urinalysis Values |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs: Blood Pressure Measurements |
1; 1; 1; 0; 1; 1 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate |
63.7; 64.5; 1.2; 5.1; 8.4; 5.7 | — |
| SECONDARY Change From Baseline in ECG Parameters: QT Interval and QT Interval Corrected by the Fridericia Formula (QTcF) |
422.1; 408.9; 2.6; -9.3; -24.3; -15.6 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women 50-85 years of age scheduled to undergo primary total hip or knee replacement surgery.
- Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 .
Exclusion Criteria
- Blood coagulation disorders.
- Participants who started chronic anticoagulant therapy (warfarin, heparin, low-molecular weight heparin, or Factor Xa inhibitors) in the last 6 months
- Hypercoagulable state.
- Prior hypersensitivity to any human blood product including plasma.
- Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
- History of immunoglobulin A or haptoglobin deficiency.
- Major surgery, trauma or injury in the last 3 months or minor surgery in the last 1 month.
- Heart disease or congestive heart failure in the 6 months prior to dosing.
- Poorly controlled hypertension.
- Severe anemia.
- Functional impairment of major joint or lower extremity other than joint undergoing surgery.
Data sourced from ClinicalTrials.gov (NCT03981419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.