Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

TAPS is a sequential trial which aims to investigate whether the administration of a blood transfusion pre-operatively to patients with sickle cell disease (HB SS or Hb SB0 thal)having low or medium risk elective surgery increases or decreases the overall rate of peri-operative complications. The proportion of patients with peri-operative complications in two randomised groups of transfused and untransfused patients will be compared.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TAPS2 Transfusion Antenatally in Pregnant Women With SCD

NCT03975894

Sickle Cell Disease Pregnancy, High Risk Blood Transfusion Complication

UNKNOWN PHASE2

The Impact of Oxidative Stress on Erythrocyte Biology

NCT04028700

Sickle Cell Disease Without Crisis

TERMINATED PHASE2

Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies

NCT00777231

Sickle Cell Disease

COMPLETED PHASE1/PHASE2

Stroke Prevention in Sickle Cell Anemia (STOP 1)

NCT00000592

Anemia, Sickle Cell Cerebral Embolism and Thrombosis Cerebrovascular Disorders +2 more

COMPLETED PHASE3

A Blood Stem Cell Transplant for Sickle Cell Disease

NCT03249831

Sickle Cell Disease Sickle Cell Disorder Hemoglobinopathies +2 more

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sickle Cell Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Patients will not receive a pre-operative transfusion.

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

Pre-operative red blood cell transfusion

B

Patients will receive a pre-operative blood transfusion. Those presenting with an admission Hb of less than 9g/dL will receive a simple (also called a 'top-up') transfusion, those presenting with an admission Hb of more than or equal to 9g/dL will undergo a partial exchange transfusion.

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

Pre-operative red blood cell transfusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Red blood cell transfusion

Pre-operative red blood cell transfusion

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Sickle cell disease, either Hb SS or Hb SB0 thal, confirmed by Hb electrophoresis, Deoxyribonucleic Acid (DNA) analysis or High Performance Liquid Chromatography (HPLC)
* At least 24 hourse and no more than 14 days before surgery and a date for surgery has been given
* Surgery to be low or medium risk
* Surgery to be with general or regional anaesthesia
* Written informed consent from patient/parent/guardian is given
* More than six months since previous TAPS trial surgery.

Exclusion Criteria

* Having a procedure involving intravascular contrast radiography or an imaging procedure
* On a regular blood transfusion regime
* Had a blood transfusion within the last three months
* The planned procedure involves local anaesthetic only
* Haemoglobin level at randomisation less than 6.5g/dL
* Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation)
* Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome
* Oxygen saturation at randomisation less than 90%
* Patient is on renal dialysis
* Already entered twice into the TAPS trial
* The physician is unwilling to randomise the patient (such patients will be entered into a trial log).

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No