This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching (NCT01328262), a randomized na study. The primary outcome is Hemoglobin Concentration Change.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01328262 |
| Phase | NA |
| Condition | Anemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Haukeland University Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Participants with anemia enrolled in a randomized clinical trial. The registry reports enrollment of 12; further eligibility details and a defined analysis population are not reported in the registry record.
Intervention
Calculated red blood cell transfusion. In this group, the hemoglobin dose needed was to be calculated for the individual patient.
Comparator
Standard red blood cell transfusion, described as transfusion of the prescribed number of red cell units.
Primary question
How did hemoglobin concentration change after transfusion in the calculated-dose and standard-treatment groups? The study description also asks whether a targeted hemoglobin increment of 2 grams per decilitre can be predicted from the hemoglobin dose and weight of the transfused blood bag.
The registry describes a hypothesis that matching hemoglobin dose to an individual patient's needs would reduce total use of red cell concentrates. That proposed reduction is not the posted primary endpoint: the listed primary outcome is change in hemoglobin concentration after transfusion. The registry record does not post an outcome measure for total red cell concentrate use, so the hemoglobin results alone cannot answer whether use was reduced.
The observed summaries are based on 6 participants in each group. That is a limited amount of information for assessing how consistently the approaches differ, especially because no inferential analysis is posted. The group summaries can be read as descriptions of the recorded hemoglobin changes, not as a definitive estimate of an underlying treatment effect or as evidence that one approach is better. Relevant details about eligibility, participant characteristics, and analysis populations are not reported in the registry record.
3. Trial Design
The registry identifies this as a randomized, parallel-group trial with no masking. Participants were assigned to a Hemoglobin Dose group, which received calculated red blood cell transfusion, or a Standard Treatment group, which received standard red blood cell transfusion. The record lists enrollment of 12 and reports 6 participants in each group for the primary outcome. The phase is listed as NA, and the study kind is recorded as other.
The study description frames the clinical question around predicting a targeted hemoglobin increment of 2 grams per decilitre using the hemoglobin dose and weight of the transfused blood bag. In the test group, the dose needed was to be calculated; in the control group, the prescribed number of red cell units was to be transfused. The stated hypothesis concerned reducing total use of red cell concentrates by matching dose to individual needs.
The registry lists the study start as 2010-11 and primary completion as 2011-02. Its current status is TERMINATED. The reason for termination, details of the randomization sequence and allocation concealment, and the intended duration of follow-up are not reported in the registry record. The record also does not describe whether participants, clinicians, or outcome assessors were aware of assignments beyond listing masking as NONE.
Randomization is a design feature intended to reduce systematic differences between groups. It does not guarantee that groups will be alike in every characteristic, and with 6 participants in each group, chance imbalances may be important. No baseline characteristics or adjustment methods are reported, so the extent of any such imbalance cannot be assessed from the registry results.
The available registry results cover the primary hemoglobin change outcome. No secondary outcomes are posted, and the record lists no analyses. Sample-size justification, planned interim analyses, and the statistical plan are not reported in the registry record. The trial design therefore establishes the intended comparison, while the posted information does not establish how the investigators planned to analyze it or why enrollment was set at this level.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Hemoglobin Dose | Standard Treatment |
|---|---|---|
| STARTED | 6 | 6 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Hemoglobin Dose | Standard Treatment | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 6 | 12 | |
| Age, Continuous | years | 80 (70 to 89) | 76 (62 to 88) | 78 (62 to 89) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 5 | 4 | 9 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Norway | participants | 6 | 6 | 12 |
| Body Surface Area | m^2 | 1.81 (1.64 to 2.15) | 1.75 (1.52 to 2.01) | 1.78 (1.52 to 2.15) |
| Blood Volume | liter | 4.7 (4.2 to 5.8) | 4.4 (3.3 to 5.4) | 4.6 (3.3 to 5.8) |
6. Primary Endpoint
The registry lists the primary outcome as Hemoglobin Concentration Change, measured over Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | g/dl |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in hemoglobin concentration after transfusion, measured in g/dl. The registry defines change as hemoglobin after transfusion minus hemoglobin before transfusion. The measurement timeframe is from 30 min to 24hours after transfusion, using the earliest observation recorded. Thus, the endpoint describes the change recorded at an early post-transfusion measurement rather than a longer-term pattern.
Hemoglobin change is relevant to the study's stated aim because the investigators sought to assess whether a targeted increment of 2 grams per decilitre could be predicted from the hemoglobin dose and weight of the blood bag. A measured change offers a direct description of the concentration response recorded after transfusion. However, the primary endpoint does not itself measure whether the target was accurately predicted, how much blood product was used, or whether total use of red cell concentrates was reduced.
The registry reports a mean and a full range for each group. A mean describes the group's average recorded change; the full range gives the lowest and highest recorded values. A range is not a confidence interval and does not quantify the precision of the mean. No standard deviation or confidence interval is reported. The timing rule also matters: because the earliest recorded observation within the stated timeframe was used, the results concern those recorded early measurements and cannot be taken as a description of later hemoglobin change.
The registry does not report an endpoint population definition, missing-measurement rules, or details of the measurement procedure. Those omissions limit assessment of how comparable and complete the endpoint observations were across participants.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The mean hemoglobin change reported for the Hemoglobin Dose group is 1.8 g/dl, with a full range from 1.2 to 2.3. For the Standard Treatment group, the reported mean is 2.0 g/dl, with a full range from 1.8 to 2.2. Each result is based on 6 participants. These are descriptive summaries of the posted measurements.
The group means are numerically different, and the ranges overlap. Those observations do not establish whether the groups differ beyond the variation that might arise from sampling. The registry reports no confidence interval, hypothesis test, p-value, or adjusted estimate for the comparison. It therefore does not provide a measure of inferential uncertainty around a group contrast. No contrast should be inferred by subtracting the two posted means; the record does not report a sponsor analysis, and no recalculated comparison is posted.
In general, a confidence interval expresses uncertainty about an estimated quantity, while a p-value addresses compatibility of data with a specified statistical model and null hypothesis. Neither can be recovered from the group means and full ranges alone. The range records observed extremes, not the precision of an estimated mean. The absence of an inferential result means the registry does not establish how compatible the observed summaries are with no group difference or with a range of possible differences.
The study's stated hypothesis includes reducing total use of red cell concentrates. The posted primary results concern hemoglobin concentration change, not product use. No result for total use is reported in the registry record. Consequently, the primary outcome summaries do not show whether the hypothesized reduction in use occurred.
Interpretation is further constrained by enrollment of 12 and by the lack of posted baseline information, missing-data methods, and analysis-population details. Randomization supports a comparative design, but it cannot remove uncertainty from a small dataset or compensate for outcome and analysis information that is not reported. The TERMINATED status is recorded, but the reason is not reported. Without that context, it is not possible to judge whether termination affected recruitment, follow-up, or analysis.
Overall, the posted data describe early post-transfusion hemoglobin changes in the two assigned groups. They do not supply a precise comparative estimate, a statistical test, or results for the proposed red cell use outcome. The summaries should be read as limited descriptive evidence rather than a conclusive assessment of the study hypothesis.
9. Statistical Methods Explained
The registry identifies the primary outcome parameter as a mean and its dispersion as a full range. These describe different aspects of the observed data. The mean represents the average recorded hemoglobin change within a group. The full range reports the smallest and largest recorded changes. A range does not show how observations are distributed between those extremes, and it is not a standard error or confidence interval. The registry does not report standard deviations or confidence intervals for the primary outcome.
What does a mean tell the reader?
A group mean condenses the participants' measurements into one central summary. It is useful for describing the average recorded change, but it does not show whether individual measurements cluster near that average or vary substantially. The reported full range adds information about observed extremes, but it cannot reconstruct the underlying distribution. With only 6 participants reported in each group, the mean and range summarize a small set of observations. Neither alone establishes how well the results would generalize to other participants.
Why is a confidence interval different from a range?
In general, a confidence interval is an inferential summary that describes uncertainty around an estimated quantity under a statistical procedure. A full range instead describes the observed spread between the lowest and highest values in the data. The posted ranges, 1.2 to 2.3 for Hemoglobin Dose and 1.8 to 2.2 for Standard Treatment, are explicitly reported as full ranges. They must not be interpreted as confidence intervals or as limits on the plausible treatment effect. Because no confidence interval for a between-group contrast is reported, the precision of that contrast cannot be assessed from the registry results.
What can randomization support?
In general, random assignment is used to make treatment groups comparable in expectation, reducing the risk that a systematic assignment process determines who receives each intervention. Randomization does not ensure that all characteristics are balanced in a particular trial, especially when the groups are small. A transparent assessment would usually consider baseline characteristics, assignment procedures, and the analysis approach. These details are not reported in the registry record. The record does identify the design as randomized and parallel, and masking as NONE, but it does not give enough detail to assess allocation concealment or the handling of deviations from assigned treatment.
Why is no inferential comparison available?
The registry posts group means and full ranges but lists no analyses. It does not report a statistical test, p-value, confidence interval for a contrast, or adjusted comparison. The summaries do not contain enough information to reconstruct such an analysis reliably: the distribution of observations and other details relevant to inference are unavailable. No new comparison should be inferred from the posted group summaries. The registry also does not report a statistical analysis plan, so it is not possible to establish which comparison or model was intended.
In general, inferential methods quantify uncertainty under assumptions about the data and analysis. Different approaches may be appropriate depending on the outcome distribution, study design, and prespecified question. When counts are limited or data are irregular, model assumptions and the influence of individual observations can matter. The registry does not report distributional diagnostics, model choices, or sensitivity analyses for this endpoint. It is therefore not possible to assess those assumptions or determine whether an alternative method was considered.
What does the measurement timeframe imply?
The outcome is defined as post-transfusion hemoglobin minus pre-transfusion hemoglobin, with the earliest observation recorded from 30 min to 24hours after transfusion used. This rule makes timing part of the endpoint definition. In general, measurements made at different times can reflect different points in a changing response, so consistent timing can matter for comparisons. The registry does not report the actual measurement times for participants or the procedure used to select the earliest recorded observation when data were available. The reported result should therefore be understood according to the registry's stated timeframe, without assuming more detailed timing uniformity.
The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Those assumptions describe a planning framework, not observed power and not the trial's own design rationale. The registry does not report a sample-size justification, and no numerical planning result is available in the record. Such an illustration cannot substitute for a prespecified design calculation or demonstrate that the trial had adequate precision.
Finally, the record lists one primary outcome, no secondary outcomes, and no analyses. It does not state how missing measurements were handled, whether analyses followed randomized assignment, or whether any participants were excluded from the primary analysis. Without these details, even the relationship between the reported group counts and the intended analysis population remains unclear. The posted statistics can be interpreted descriptively, but the registry does not support a fuller reconstruction of the analysis methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, Hemoglobin Concentration Change, and 0 secondary outcomes posted. It lists 0 analyses. These entries do not describe a completed inferential analysis or any adjustment for multiple testing. The statistical plan and any multiplicity procedure are not reported in the registry record.
In general, multiplicity concerns arise when several outcomes, comparisons, or analysis choices are examined, because repeated testing can affect the interpretation of statistical evidence. The single listed primary outcome narrows the visible outcome set, but it does not establish whether other outcomes or analyses were planned or considered. The registry does not report that information, so no conclusion about the investigators' full multiplicity strategy is possible.
Missing-data handling is also not reported in the registry record. The record does not state whether measurements were missing, how any missing values were treated, or whether participants with unavailable measurements were included in an analysis. The population field for the primary outcome is blank, and a defined analysis population is not reported. Although 6 participants are reported in each group for the outcome, the record does not explain how these counts relate to the randomized population or whether all randomized participants contributed measurements.
These omissions matter because decisions about missing observations and analysis populations can affect group summaries and comparisons. Without the relevant rules and participant flow, the reader cannot assess whether the posted outcome data represent all randomized participants or a subset selected by data availability. The registry does not report an intention-to-treat analysis, a per-protocol analysis, or sensitivity analyses, and none should be assumed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Hemoglobin Dose | 0 | 6 | 0.0% |
| Standard Treatment | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hemoglobin Dose | 0 of 6 |
| Standard Treatment | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Hemoglobin Dose | 0 of 6 |
| Standard Treatment | 0 of 6 |
The registry reports 0 serious adverse events affecting participants in the Hemoglobin Dose group, where 6 were at risk, and 0 in the Standard Treatment group, where 6 were at risk. It also reports 0 other adverse events affecting participants in each group and 0 deaths in each group. No serious adverse event terms are listed.
These figures mean that the registry records no affected participants in the posted adverse-event categories during the period covered by the record. They do not establish that no adverse events occurred outside the categories or reporting period captured, and they do not demonstrate that the two approaches have equivalent safety. With 6 participants reported at risk in each group, the safety observations are limited. The registry does not report the safety monitoring period, event definitions, or additional details about collection and adjudication. The counts should therefore be read as the adverse-event results recorded in the registry, not as a comprehensive estimate of risk.
12. What the Result Does, and Does Not, Mean
The result establishes that the registry contains descriptive early post-transfusion hemoglobin change summaries for two randomized groups: a mean of 1.8 g/dl and full range of 1.2 to 2.3 in Hemoglobin Dose, and a mean of 2.0 g/dl and full range of 1.8 to 2.2 in Standard Treatment. The reported group size is 6 participants in each arm. These summaries describe what was recorded for those participants; they do not by themselves estimate the precision of a group difference.
The data do not establish a statistically supported difference between the transfusion approaches. No inferential comparison, confidence interval, or p-value is reported. The values do not show whether a targeted hemoglobin increment of 2 grams per decilitre was accurately predicted for individual patients, because the registry does not report a prediction-accuracy result. Nor do they establish whether total use of red cell concentrates was reduced: that proposed outcome is not posted as a result.
In general, a randomized comparison can help distinguish treatment effects from some forms of systematic bias, but its interpretation still depends on the amount and completeness of data, the conduct of randomization, and the planned analysis. Here, baseline characteristics, missing-data methods, the analysis population, and the statistical plan are not reported in the registry record. The study's TERMINATED status is recorded, while the reason for termination is not reported. Those gaps limit conclusions about how the posted results relate to the intended study.
The absence of posted secondary outcomes and analyses also limits the scope of interpretation. The primary endpoint is a hemoglobin concentration change measured at the earliest recorded observation within the stated timeframe. It cannot be taken as evidence about longer-term hemoglobin patterns, product use, or outcomes that are not reported. The appropriate reading is therefore narrow: the registry records these group summaries, while the comparative uncertainty and broader hypothesis remain unresolved by the posted results.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a randomized design and an adequately reported comparative analysis. The registry identifies randomization and a parallel-group structure, but it posts only group means and full ranges for the primary endpoint, with no analyses listed. A design can establish the intended comparison; it does not itself supply an estimate of the comparison's uncertainty.
The endpoint also illustrates the importance of matching the reported outcome to the study hypothesis. The stated hypothesis concerns reducing total use of red cell concentrates through dose matching. The posted primary result is hemoglobin concentration change. That endpoint is relevant to the goal of achieving a hemoglobin increment, but it is not a direct measure of total product use. Without a posted use outcome, the proposed resource-use question remains unanswered in the registry record.
The distinction between observed range and inferential precision is important in a small study. A full range conveys the observed extremes, while a confidence interval would address uncertainty in an estimated quantity. The record reports the former but not the latter. The reported data can therefore support description, but not a precise estimate of how the groups compare.
Finally, the absence of information about missing data, analysis populations, and the statistical plan limits reproducibility and critical appraisal. Such details help readers understand which participants contributed to results and how the comparison was intended to be made. Their absence does not erase the descriptive results, but it constrains what can be concluded from them. The trial highlights why interpretation depends on both outcome alignment and transparent reporting of analysis methods.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation specific to this trial is the small reported group size: 6 participants in each arm, within an enrollment of 12. The registry provides no confidence interval or inferential comparison for the primary outcome, so the precision of any difference between groups is not reported. Means and full ranges alone do not establish how stable the estimates are or how much individual observations influence them.
The registry reports the outcome as the earliest hemoglobin observation recorded from 30 min to 24hours after transfusion, but does not give participant-level measurement times or describe measurement procedures. A defined analysis population is not reported, and the record does not explain missing measurements, exclusions, or whether all randomized participants contributed to the outcome summaries. Baseline characteristics are also not reported, limiting assessment of group comparability after randomization.
The stated hypothesis includes reducing total red cell concentrate use, but the posted primary outcome is hemoglobin concentration change and no result for total use is reported. No secondary outcomes are posted. This leaves the resource-use hypothesis unassessed by the outcomes available in the registry record.
The trial is marked TERMINATED, but the reason is not reported. The record does not provide the statistical analysis plan, sample-size justification, interim-analysis information, or details of allocation concealment. These omissions prevent assessment of whether the planned design and analysis were followed. The posted summaries should consequently be interpreted as limited descriptive results, with substantial uncertainty about the intended comparative analysis and the broader study aims.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching — NCT01328262.
- Registry record last updated 2025-04-17; status last verified 2019-02.
- Results first posted 2025-04-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01328262 is titled “A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching” and is sponsored by Haukeland University Hospital. The registry lists a randomized, parallel-group design with no masking, enrollment of 12, and phase NA. The study start is recorded as 2010-11, primary completion as 2011-02, and status as TERMINATED.
The comparison is between calculated red blood cell transfusion and standard red blood cell transfusion. The primary outcome is hemoglobin concentration change, defined as the post-transfusion value minus the pre-transfusion value, using the earliest recorded measurement from 30 min to 24hours after transfusion. The registry reports means and full ranges for 6 participants in each group. It lists no analyses and no secondary outcomes. The termination reason, statistical plan, missing-data approach, and defined analysis population are not reported in the registry record.